Returned for evaluation was a mariner berenstein 4fx130cm catheter.A visual review of the device noted that the tip is separated from the catheter shaft.Also noted the catheter tip had splits at the end of the catheter tip.The catheter met id dimensional measurement specifications for this device.Due to the tip damage (split) dimensional of the od was unable to be performed.The customer's reported complaint description of the proximal end separating from the distal is confirmed.This failure mode is consistent with tip embrittlement associated with capa (b)(4).Capa (b)(4) was closed in august 2017.The processing of this reported catheter commenced prior to implementations of the soft tip material change.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.The instructions for use, which is supplied to the end user with states; "never advance or retract an angiographic catheter or guidewire against resistance.This may result in damage to the vessel, the product, or both.Do not attempt to hand straighten the tip of any curved tipped catheters which are furnished with a tip straightener.This may result in damage to the product.Tip straighteners are furnished on all catheters intended to be straightened with the aid of a tip straightener.Reshaping of the catheter tip is not recommended.Physical damage to the catheter material can result when exposed to heat.Do not leave curved tipped catheters straightened over guidewires for extended periods of time.This will result in failure of the catheter tip to re-form to its intended shape." a review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint # (b)(4).
|