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

Catalog Number CQ5058J

Device Problems Material Frayed (1262); Peeled/Delaminated (1454); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2018

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 return of the device is pending.The investigation of the reported event is currently underway.The catalog number identified in section has not been cleared in the us, but is similar to the conquest pta dilatation balloon products that are cleared in the us.The 510 k number and pro code for the conquest pta dilatation balloon products are identified.Accordingly, this event has been determined to be mdr reportable.(expiry date: (b)(6) 2019).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, the pta balloon allegedly ruptured at rated burst pressure.There was no reported patient injury.

Manufacturer Narrative

The device history records have been reviewed and 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 that has been reported for this corporate lot number to date.The device was returned for evaluation.A visual inspection found peeled outer layer and frayed fibers on the distal cone of the balloon.The device was inflated and water was seen exiting from a partial circumferential rupture.Therefore, the investigation is confirmed for peeled outer layer, frayed fibers, and for a circumferential rupture.The definitive root cause for the identified issues could not be determined based upon the available information.An investigation is currently open to address the peeling outer layer issue.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured at rated burst pressure.There was no reported patient injury.

• Brand Name: CONQUEST PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7807273
• MDR Text Key: 117960576
• Report Number: 2020394-2018-01521
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741127168
• UDI-Public: (01)00801741127168
• Combination Product (y/n): N
• PMA/PMN Number: K083657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CQ5058J
• Device Lot Number: REAX0856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Date Manufacturer Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 43