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

Model Number CQF75124

Device Problems Material Frayed (1262); Peeled/Delaminated (1454); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2018

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.Expiry date: 07/2021.

Event Description

It was reported that during an angioplasty procedure in the right brachiocephalic vein, frayed balloon material was allegedly found upon removing the balloon from the patient.Reportedly, a stent was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: 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.Investigation summary: the device was returned for evaluation.A visual inspection found circumferential fibers to be unraveled on the barrel of the balloon, and pebax was noted to be slight peeled on the distal cone of the balloon.Therefore, the investigation is confirmed for both peeled pebax and unraveled fibers.However, the investigation is unconfirmed for the reported frayed material, as the fibers were not found to be frayed.It is likely the user perceived the unraveled fibers as frayed fibers.The definitive root cause for the identified unraveled fibers and peeled pebax could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 07/2021).

Event Description

It was reported that during an angioplasty procedure in the right brachiocephalic vein, frayed balloon material was allegedly found upon removing the balloon from the patient.Reportedly, a stent was used to complete the procedure.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: 8035279
• MDR Text Key: 126078576
• Report Number: 2020394-2018-01978
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060663
• UDI-Public: (01)00801741060663
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

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 Model Number: CQF75124
• Device Catalogue Number: CQF75124
• Device Lot Number: RECU2363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Manufacturer Received: 10/08/2018
• Initial Date FDA Received: 11/02/2018
• Supplement Dates Manufacturer Received: 12/15/2018
• Supplement Dates FDA Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1