The account alleges that during a fistula procedure the clinician was attempting to use the ellipsys device during fistula procedure.It was alleged there was no vessel tortuosity, the artery diameter was 2.5mm and vein diameter was 3mm.The distance between artery and vein was not greater than 1.5mm.Ifu was followed.It is alleged that during the procedure while the catheter was being pulled back across the anastomosis, it did not catch on the arterial wall and was retracted into the vein at which point it became stuck.Neither the catheter nor the sheath would advance or retract.The catheter was rotated and at one point closed to try and help advance or retract, but was unsuccessful.The clinician used force to remove the catheter and sheath together while maintaining wire access.It is believed the catheter may have become stuck on a valve in the perforating vein.The account alleges that the device was stuck around the outside of the sheath and both had to be removed together.A small hematoma formed and a slightly larger exit hole was created in the anterior vein wall.This was resolved with prolonged pressure hold and a suture at the skin entry point.A new catheter and sheath were inserted over the original wire and the procedure was successfully completed.No additional patient consequence to report.
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The suspect device will not be returning for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned at a later date, the investigation will be re-opened.
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