En Instructions For Use; Nit-Occlud® Pda; Product Description; General Information And Warnings - PFM Medical Nit-Occlud PDA Gebrauchsanweisung

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Instructions for Use
Nit-Occlud® PDA

Product description

Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with spiral coils. The system consists of the fol-
lowing parts:
• Nit-Occlud® PDA
The spiral coil is mounted in a straightened fashion on a flexible delivery system including a disposable handle to which it is connected by
means of a patented detachment mechanism.
Nit-Occlud® PDA coils are available in 3 different types: Flexible, Medium, Stiff.
The flexible and medium types are pre-loaded into the transportation sheath. For insertion the transportation sheath must be connected to
the implantation catheter. The stiff type is pre-loaded in a 5F implantation catheter. For insertion, an additional long introducer sheath (5 F
or larger) is required.
The Nit-Occlud® PDA coil has a cone in cone configuration which results from the fact
that the proximal windings of the coil are wound in the reverse direction (see Fig.).
Fig.: Nit-Occlud® PDA spiral coils
(D=Distal diameter, P=Proximal diameter, Lc=Length configurated).
• Implantation catheter
The implantation catheter is equipped with a marker ring at its distal tip for better orientation during fluoroscopy.

General Information and Warnings

These instructions for use and the information on the packaging should be read carefully before each use. The PDA coil system should be used
only by physicians trained in interventional occlusion techniques.
WA R N I N G S
Do not use the product if the packaging has been opened, or is damaged, if you are not sure that it is sterile, or if the
expiry date has passed.
Each product is packed separately, and is delivered in an EO-sterilised and pyrogen-free condition. It is intended for
single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization of single-use devices
may result in degraded performance or a loss of functionality. Reuse of single-use devices may result in exposure to
pathogens such as viruses, bacteria, fungi, or prions.
The product must be stored in dry conditions. Do not expose the packaged products to direct sunlight.
Retrieval devices should be available during implant procedures for interventional retrieval of the coil if required.
Care must be taken not to damage the coil or to dislodge it from the delivery system while unpacking or inserting it
into the implantation catheter.
Since the delivery system has ferromagnetic properties, implantation must not be carried out in an MR environ-
ment.
The coil should not be removed from the delivery system. It should not be used with another delivery system since
this may alter characteristics of configuration and detachability.
A detached coil should not be remounted on the core wire of the delivery system.
The configured coil should not be pulled through heart valves or ventricular chambers.
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The implantation catheter is not suitable for application of contrast medium. It must not be connected to high pres-
sure injectors
The Nit-Occlud® PDA coil consists of a nickel-titanium alloy, which is generally considered safe. In non-clinical test-
ing, nickel has been shown to be released from the device in very small amounts. Nickel is a known sensitizing agent,
therefore the medical history of the patient regarding nickel or other metal allergies should be carefully established.
Patients should be instructed to report after implantation of the device any symptoms that might indicate an aller-
gic reaction, e.g. difficulty of breathing or inflammation of the face or throat. Non-clinical testing acc. to ISO 10993-
10 has shown the device to be non-irritating and non-sensitizing, however there is still a small risk that the nickel
released from the device may cause patients to develop an allergy to nickel.
Nickel is also known to be a genotoxic and carcinogenic agent under certain conditions. Non-clinical testing acc. to
ISO 10993-3 has shown the device to be non-mutagenic and not genotoxic. Based on the results of non-clinical test-
ing, the amount of nickel expected to be released from the device after implantation is only a very small fraction
of the patient's dietary nickel intake and considerably below the tolerable intake suggested by various Regulatory
Agencies/Advisory Bodies.

Product Identification

Each product label has peel-off labels, to allow the product to be identified precisely. These can be used for the patient file and the patient
ID card.
MRI Compatibility
The Nit-Occlud® PDA coil was determined to be MR-conditional according to the terminology specified in the American Society for Testing
and Materials (ASTM) International, Designation: F2503-05. Standard Practice for Marking Medical Devices and Other Items for Safety in
the Magnetic Resonance Environment. ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, Pennsylvania, 2005.
Non-clinical testing demonstrated that the Nit-Occlud® PDA coil is MR conditional. A patient with this device can be scanned safely im-
mediately after placement under the following conditions:
Static Magnetic Field
• Static magnetic field of 3 Tesla or less
• Maximum spatial gradient magnetic field of 720 Gauss/cm or less
MRI-Related Heating
• I n non-clinical testing, the Nit-Occlud® PDA coil produced the following temperature rise during MRI performed for 15-min in the
3-Tesla (3-Tesla/128-MHz, Excite, HDx, Software 14X.M5, General Electric Healthcare, Milwaukee, WI) MR system: Highest temperature
change +1.6°C.
Therefore, the MRI-related heating experiments for the Nit-Occlud® PDA coil at 3-Tesla using a transmit/receive RF body coil at an
MR system reported whole body averaged SAR of 2.9 -W/kg (i.e., associated with a calorimetry measured whole body averaged value
of 2.7-W/kg) indicated that the greatest amount of heating that occurred in association with these specific conditions was equal to
or less than +1.6°C.
Artifact Information
• M R image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the Nit-
Occlud® PDAcoil. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary.
Pulse Sequence
Signal Void Size
Plane Orientation
06.07.2012_Rev08 06.07.2012_Rev08
T1-SE T1-SE GRE
369 mm 2 118 mm 2 647 mm
Parallel Perpendicular Parallel
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GRE
2 739 mm 2
Perpendicular
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