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

Model Number CQF7554

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the reported malfunction, a lot number was provided, and a lot history review was performed.The sample was returned for evaluation.After further evaluation, the investigation confirmed for the reported balloon rupture, as a pinhole rupture was noted to the balloon, additionally the investigation also confirmed for the identified peeling pebax.The definitive root cause for the balloon rupture and peeled pebax could not be determined based upon available information.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the malfunction indicated that model cqf7554 pta balloon dilatation catheter allegedly peeled and experienced material rupture.This report was received from one source.This event involved a patient with no patient consequences.Age, weight, and gender were not provided for this patient.

• 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
• 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 ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9596527
• MDR Text Key: 178356953
• Report Number: 2020394-2020-00455
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060397
• UDI-Public: (01)00801741060397
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2020

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: No Information
• Device Model Number: CQF7554
• Device Catalogue Number: CQF7554
• Device Lot Number: REDR4138
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/16/2020
• Type of Device Usage: N
• Patient Sequence Number: 1