MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number CQF7564

Device Problems Peeled/Delaminated (1454); Material Rupture (1546); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2018

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 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 superficial femoral artery, the pta balloon allegedly ruptured after being removed from the patient.Another pta balloon was used to complete the device.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 reported to date for this lot number and failure mode.The device was returned for evaluation.A visual inspection found the outer pebax layer to be peeled from the balloon throughout the balloons length.Additionally, the circumferential fibers were noted to be unraveled from the balloon.The device was inflated and water was seen exiting the balloon from a pinhole rupture.Therefore, the investigation is confirmed for both peeled pebax and unraveled fibers, as well as for a pinhole rupture.Per the reported event details, the vessel being treated was 'massively calcified.' therefore, it is possible that patient factors contributed to the identified fiber and pebax issues.However, the definitive root cause for the identified issues could not be determined based upon available information.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(b)(4).

Event Description

It was reported that during an angioplasty procedure in the superficial femoral artery, the pta balloon allegedly ruptured after being removed from the patient.Another pta balloon was used to complete the device.There was no reported patient injury.

• Brand Name: CONQUEST 40 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: 7754860
• MDR Text Key: 116233850
• Report Number: 2020394-2018-01380
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060441
• UDI-Public: (01)00801741060441
• Combination Product (y/n): N
• PMA/PMN Number: K120660
• 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: 10/04/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: CQF7564
• Device Catalogue Number: CQF7564
• Device Lot Number: RECR0696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Initial Date Manufacturer Received: 07/10/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 09/28/2018
• Supplement Dates FDA Received: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR