|
Model Number CQ7594 |
Device Problems
Material Frayed (1262); Peeled/Delaminated (1454)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 12/19/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
|
|
Event Description
|
It was reported that during an angioplasty procedure in the cephalic vein, frayed material was found at the distal tip of the pta balloon upon removal from the patient.Another pta balloon was used to complete the procedure.There was no reported patient injury.
|
|
Manufacturer Narrative
|
Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation.A visual inspection found peeled pebax and a frayed fiber on the balloon.Therefore, the investigation is confirmed for both peeled pebax, and frayed material.The definitive root cause for the identified issues could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Labeling review: the current ifu (instructions for use) states: when the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated.If resistance is met during manipulation, determine the cause of the resistance before proceeding.Applying excessive force to the catheter can result in tip breakage or balloon separation.Use of the conquest pta dilatation catheter: apply negative pressure to fully evacuate fluid from the balloon.Confirm that the balloon is fully deflated under fluoroscopy.While maintaining negative pressure and the position of the guidewire, withdraw the deflated dilatation catheter over the wire through the introducer sheath.Use of a gentle counterclockwise motion may be used to help facilitate catheter removal through the introducer sheath.
|
|
Event Description
|
It was reported that during an angioplasty procedure in the cephalic vein, frayed material was found at the distal tip of the pta balloon upon removal from the patient.Another pta balloon was used to complete the procedure.There was no reported patient injury.
|
|
Search Alerts/Recalls
|
|
|