MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA BALLOON DILATATION CATHETER; CATHETER, PERCUTANEOUS

Model Number	CQ7582
Medical Device Problem Codes	Break (1069); Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that during an angioplasty of a cephalic vein fistula, an alleged break occurred in the catheter shaft.Upon removal from the patient the catheter shaft allegedly broke in a different location.The balloon, guidewire, and sheath were removed together as one unit.It was further reported that a new balloon was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
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.The device was returned for evaluation.A visual inspection found the outer catheter shaft to be broken and brittle throughout its length.Therefore, the investigation is confirmed for the reported catheter break.The returned sheath was noted to have a flared tip, and the returned balloon was noted to be bunched toward the distal end.Therefore, the investigation is confirmed for sheath-related retraction issues.It is unknown how the catheter shaft became brittle.The root cause is likely not manufacturing related as a 100% visual inspection is performed per spec.Additionally, an aql sample inspection is performed per spec.It is possible that external factors during shipping of the device contributed to the brittle nature of the shaft.However, the definitive root cause for the breaks or retraction issues could not be determined based upon available information.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: position the balloon relative to the lesion to be dilated, ensure the guidewire is in place and inflate the balloon to the appropriate pressure.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.(b)(4).
Event or Problem Description
It was reported that during an angioplasty of a cephalic vein fistula, an alleged break occurred in the catheter shaft.Upon removal from the patient the catheter shaft allegedly broke in a different location.The balloon, guidewire, and sheath were removed together as one unit.It was further reported that a new balloon was used to complete the procedure.There was no reported patient injury.

• Brand Name: CONQUEST PTA BALLOON DILATATION CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7063868
• Report Number: 2020394-2017-01649
• Device Sequence Number: 13936462
• Product Code: DQY
• UDI-Device Identifier: 00801741063091
• UDI-Public: (01)00801741063091
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K083657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: CQ7582
• Device Catalogue Number: CQ7582
• Device Lot Number: REZC0656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Initial Date Received by Manufacturer: 11/02/2017
• Supplement Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 11/28/2017
• Supplement Report FDA Received Date: 01/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 82