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EQUIPMENT REQUIRED
RF transseptal procedures should be performed in a specialized clinical setting
equipped with appropriate imaging equipment and compatible examination table,
echocardiography imaging, physiologic recorder, emergency equipment and
instrumentation for gaining vascular access. Ancillary materials required to
perform this procedure include:
•
RFP-100A Baylis RF Generator
•
0.035" compatible FARADRIVE Steerable Sheath (optional) and/or
dilator devices
•
DIP electrode, meeting or exceeding IEC 60601-2-2 requirements for
electrosurgical electrodes (not included)
•
0.035" guidewire or smaller (optional)
•
DuoMode™ Cable for use with electroanatomic mapping systems
(optional)
SUGGESTED DIRECTIONS FOR USE
•
Carefully read all instructions prior to use. Failure to do so may result
in complications.
•
Carefully read the applicable FARADRIVE Steerable Sheath
instructions prior to use. Failure to do so may result in complications.
•
Carefully read the applicable compatible guidewire instructions prior to
use. Observe all warnings and precautions noted in these instructions.
Failure to do so may result in patient complications.
•
Use of VersaCross Connect is expected to reduce the number of
exchanges in the procedure resulting in a more efficient transseptal
puncture. This should be taken into account when estimating the timing
for heparin administration to ensure appropriate ACT levels after
transseptal puncture.
•
Dilator may be used with a compatible sheath or as a standalone
device to facilitate access to the left atrium via transseptal puncture.
•
The VersaCross Connect Access Solution for FARADRIVE is supplied
sterile using an ethylene oxide process. Use aseptic technique when
opening the packaging and handling the products in the sterile field.
•
Connect the generator connector end of the Connector Cable to the
isolated patient connector port on the Baylis RF Generator as per the
Baylis RF Generator Instructions for Use. Gently line up the connector
pins with the socket and push in until the connector fits firmly into the
socket. Any attempt to connect the cable otherwise will damage the
pins on the connector.
•
Do not use excessive force in connecting the Connector Cable to the
Baylis RF Generator. Use of excessive force may result in damage to
the connector pins.
•
Thoroughly flush the dilator with heparinized saline solution prior to
use.
•
Perform a standard vein puncture of the right femoral vein using an
access needle (not supplied).
•
Care should be taken when inserting or removing the dilator from the
venous cutaneous puncture site; note that a compatible access
introducer sheath may be used if desired. Refer to the compatible
introducer sheath's Instructions for Use for details and directions.
•
Introduce a compatible guidewire through the vasculature access point
and advance to required depth (the VersaCross RF Wire may be
used).
•
Enlarge the cutaneous puncture site as necessary.
•
The distal curvature of the dilator may be adjusted manually if desired.
Manual shaping of the distal curve shall be done with smooth motions
along the curve. Do not use excessive force and/ or pressure when
reshaping.
•
Dilator can be inserted fully into the sheath (if sheath is used) and a
manual curve may be added to the dilator or the dilator and sheath
assembly prior to insertion into the body.
•
Thread the dilator over the VersaCross RF Wire (or guidewire if used)
using a slight twisting motion into the superior vena cava (SVC) under
imaging guidance such as fluoroscopy or echocardiography. If
resistance is encountered, DO NOT use excessive force to advance or
withdraw the dilator over the guidewire. Determine the cause of
resistance before proceeding.
•
Use standard technique to position the dilator/guidewire assembly or
the sheath/dilator/guidewire assembly (if sheath is used) into the
desired heart chamber.
•
If the VersaCross RF Wire was not used to advance the dilator to the
SVC, remove the guidewire and exchange for the VersaCross RF Wire
with the provided tip straightener.
•
Advance the VersaCross RF Wire through the dilator or the sheath and
dilator assembly (if sheath is used) until the wire tip is just within the
dilator tip. The visible markers on the wire body can be used to assist
with the positioning of the wire tip with the distal end of the dilator.
•
Firmly grasp the catheter connector end of the Connector Cable in one
hand. Using your thumb, depress the red button on the top of the
connector. Slowly insert the proximal end of the VersaCross RF Wire
into the opening of the catheter connector. Once the exposed portion
of the proximal end of the device is no longer visible, release the red
button on the connector. Gently tug on the device to ensure that you
have a secure connection.
Page 3 of 48
•
Position the tip of the transseptal assembly (RF wire, sheath (if sheath
is used), dilator) in the right atrium against the fossa ovalis under
appropriate imaging guidance including but not limited to fluoroscopic,
echocardiographic and/or electroanatomic mapping guidance using
standard technique.
•
NOTE:
If
using
electroanatomical
recommended to confirm tip placement and septal tenting with
echocardiographic imaging or another imaging modality.
•
Apply pressure to the dilator to tent the septum at the fossa ovalis.
•
Advance the VersaCross RF Wire so that the active tip is engaging the
septum at the fossa ovalis but still within the dilator.
•
Once appropriate positioning has been achieved, deliver RF power via
the Baylis RF Generator to the active tip. This results in puncture of the
targeted cardiac tissue. Please refer to the Baylis RF Generator
Instructions for Use for the correct operation of the generator.
•
Apply firm pressure to the VersaCross RF Wire during the application
of RF energy to successfully advance the VersaCross RF Wire through
the tissue.
•
NOTE: Use the lowest appropriate RF settings to achieve the desired
puncture.
o
For RFP-100A: An initial RF setting between one (1)
second on "PULSE" mode to two (2) seconds on
"CONSTANT" mode has been shown to be sufficient for
successful puncture.
•
RF power delivery can be terminated by pressing the RF ON/OFF
button on the Baylis RF Generator if the timer has not expired.
•
Entry into the left atrium can be confirmed by monitoring the
VersaCross
RF
Wire
Echocardiographic guidance is also recommended.
•
If septal puncture is not successful after five (5) RF power applications,
it is advised that the user utilize an alternate method for the procedure.
•
Once the puncture is successfully completed, the VersaCross RF Wire
should be mechanically advanced without any RF power. Positioning
in the left atrium is sufficient when the full distal curve and floppy
section have crossed the septum and are observed in the left atrium.
Echocardiographic guidance is also recommended.
•
The dilator can then be advanced over the VersaCross RF Wire to
enlarge the puncture.
•
To disconnect the VersaCross RF Wire from the Connector Cable,
depress the red button on the catheter connector and gently remove
the proximal end of the VersaCross RF Wire from the Connector
Cable.
•
To disconnect the Connector Cable from the Baylis RF Generator,
grasp the connector firmly and gently pull it straight out of the socket.
•
Retract the VersaCross RF Wire slowly through the dilator or the
transseptal sheath and dilator assembly (if sheath is used).
•
Ensure the dilator is clear of air. To aspirate blood, use the dilator hub.
•
Monitor the location of the radiopaque tip frequently under imaging
guidance, such as fluoroscopy or echocardiography.
•
Deliver a continuous heparinized solution infusion or aspirate
periodically. This may help reduce the risk of thromboembolic
complications due to thrombus formation, as there may be a possibility
of thrombus development at the distal dilator tip or inside the dilator
lumen. Also aspirate when removing the transseptal device or dilator.
•
After removal of the dilator, use standard technique to achieve
hemostasis.
Connections
Baylis RF Generator
Single-Use
Connector
Cable
(Included)
DIP Grounding Pad
(Not included)
VersaCross RF Wire
(Pigtail model shown)
Foot Switch
(Optional)
CLEANING AND STERILIZATION INSTRUCTIONS
Do not clean or re-sterilize the VersaCross Connect Access Solution for
FARADRIVE. The VersaCross Connect Access Solution for FARADRIVE is
intended for single use only.
TROUBLESHOOTING
The following table is provided to assist the user in diagnosing potential
problems.
mapping
guidance,
under
appropriate
imaging
guidance.
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