MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA VALLOON DILATATION CATHETER

Lot Number REYD1571

Device Problems Deflation Problem (1149); Product Quality Problem (1506)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2015

Event Type  Injury  

Manufacturer Narrative

The lot number was provided and , the device history records are being reviewed.The device was returned for evaluation.Investigation is currently underway.

Event Description

It was reported that the pta balloon would not deflate in the vessel.Another device was used to remove the balloon.There was no report of patient injury.

Manufacturer Narrative

A manufacturing review was conducted.The lot met all release criteria.Visual inspection: the device was returned.The balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as an 12mm x 4cm balloon.The distal portion of the balloon was prolapsed over the distal tip, indicating that the glue bullet was likely lodged in the outer catheter shaft.No other anomalies were noted to the device at this time.Functional/performance evaluation: as the condition of the returned sample indicated that the glue bullet was most likely lodged in the outer catheter shaft, no inflation/deflation testing was performed.The balloon was cut with a scalpel near the inflation deflation ports.Upon removing the balloon, it was noted that the glue bullet was not in its correct location and was lodged inside the outer catheter shaft.The polyimide was pulled distally to remove the glue bullet from the outer catheter.Upon removal, it appeared that the glue bullet was improperly formed.The stepped portion of the shaft was examined under microscopic magnification and was observed to be oval in shape.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the investigation is inconclusive for deflation issues, as the balloon was unable to be functionally tested due to the glue bullet blocking the inflation/deflation port.The investigation is confirmed for a product quality issue, as the glue bullet was improperly formed, causing the glue bullet to become lodged within the outer catheter shaft.The evaluation found the glue bullet was lodged within the catheter shaft, blocking the inflation/deflation ports.The root cause for the glue bullet becoming lodged in the catheter shaft is unknown.As the stepped portion of the catheter shaft was damaged, it is possible that excessive force was exerted on the catheter and damaged the shaft, causing the glue bullet to become lodged.It is unknown whether patient and/or procedural issues contributed to the event.(b)(4) was initiated to further investigate the conquest deflation issue complaints and identify any applicable corrective and/or preventative actions.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.Potential adverse reactions: additional intervention.

Event Description

It was reported that the pta balloon would not deflate in the vessel.Another device was used to remove the balloon.There was no report of patient injury.

• Brand Name: CONQUEST PTA VALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 4990543
• MDR Text Key: 22731843
• Report Number: 2020394-2015-01285
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2017
• Device Lot Number: REYD1571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention