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

Model Number CQF7588

Device Problems Material Frayed (1262); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A dhr review could not be conducted, as the lot number was not reported for this device.The device was returned for evaluation.A visual inspection found frayed fibers on the barrel of the balloon.The device was inflated, and a longitudinal rupture was noted at the location of the frayed fibers.Therefore, the investigation is confirmed for frayed fibers and for a longitudinal rupture.It is possible that the identified rupture contributed to the fiber disturbance.However, the definitive root cause for the identified issues 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 reported information indicated that model cqf7588 pta balloon dilatation catheter allegedly ruptured at approximately 25 atmospheres.There was no reported retraction difficulty through the sheath.The procedure was completed with another balloon catheter.There was no reported patient injury.This information was received from one source.The patient was a (b)(6) year-old male who weighed (b)(6) kilograms.

• Brand Name: CONQUEST 40 PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DIALATION 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8808999
• MDR Text Key: 151643757
• Report Number: 2020394-2019-01629
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741060571
• UDI-Public: (01)00801741060571
• 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: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CQF7588
• Device Catalogue Number: CQF7588
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 06/30/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1