FLOCARE® DirectPEG
Intended use
The Flocare® DirectPEG is a percutaneous endoscopic gastrostomy (PEG) set for the placement of
a balloon tube via introducer respectively direct puncture method directly into a patient's stomach.
The tube is placed in an inpatient setting by a physician in adults and children needing long-term
enteral feeding.
The Flocare® DirectPEG is intended to be used during the fi rst installation and creates a stoma
through the abdominal wall by introducing a trocar with a split-cannula into the stomach. After
removal of the trocar the tube is inserted through the split-cannula, the balloon is blocked with
water to keep the tube in place and the split-cannula is removed. The indicator shows if the
correct tension is applied to the tube and if the balloon is blocked optimally respectively if the
balloon is intact.
The Flocare® DirectPEG is intended for single patient use and cannot be reprocessed. It is
available in sizes CH 12 (4 mm) and CH 14 (4,67 mm). Care and aftercare may be executed by
laypersons (e.g. patients, caring relatives) and health care professionals (e.g. physicians, nursing
personnel). Removal respectively replacement of the Flocare® DirectPEG is solely conducted
by a physician.
INDICATIONS
Long-term enteral feeding, especially for patients where a PEG cannot be placed using the
pull-through method, as in the following cases:
• Only nasal endoscopy possible
• Severe stenosis of the oesophagus
• Oesophageal varices
• Oesophageal diverticula
• Caustic burns in the upper gastrointestinal tract
• Tumours in the ENT region
• Radiotherapy of the upper gastrointestinal tract
• Following mouth and throat surgery
As an alternative to the standard pull-through method in patients, such as paediatric patients,
where it is planned to replace the Flocare® DirectPEG with a button or gastrotube in order to avoid
sedation again. The physician must decide whether adequate insuffl ation is possible because this
is a precondition for the method of direct placement.
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