As reported december 07, 2016, a (b)(6), female patient presented for an medical procedure.During the procedure, standard atraumatic steel wire was used with the hockey stick for access in a biliary drainage case.As the guide wire was threaded using normal, atraumatic procedure, instead of straightening the catheter tip, the guide wire perforated the catheter side wall.No adverse outcome for patient, procedure carried on to conclusion.The guide wire product used - cook rosen curved guide wire - standard for the procedure.Catheter removed intact.There was no harm or injury to the patient due to this event.The reported defective disposable device is available for return to the manufacturer for evaluation.
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Returned for evaluation was a 4f soft-vu catheter.The tip straightener was removed and was not returned.A visual of the catheter noted a hole in the soft tip.A guidewire from stock was advanced through the catheter.The wire protrudes from the site of the perforation in the soft tip.The customer's reported complaint description of a perforation in the tip of the catheter is confirmed.A lot history records search revealed no quality related issues or manufacturing deficiencies at the time of manufacture.During the manufacturing process, manufacturing verifies that a.038" guidewire is able pass freely though the catheter.As tip straightener was not returned with the device, it is possible that the user attempted to hand straighten the tip while advancing it over the wire, inevitably, puncturing the wall of the soft tip.This is contradictory to the ifu.Though this theory cannot be definitively determined, a possible root cause could be due to the user technique.The patient was unaffected due to this event.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).
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