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

Model Number CQ75124

Device Problems Deflation Problem (1149); Material Frayed (1262); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A lot history review was conducted, and it was determined that a device history record (dhr) review was not required.The device was returned for evaluation.A visual inspection was performed, and fiber disturbance was noted.An in-house inflation device was used to inflate the balloon.Water was noted exiting the balloon.The balloon fibers were stripped and a hole from the user puncturing the balloon were noted.Therefore, the investigation is confirmed for the fiber disturbance, as disturbed fibers were noted on the balloon.The investigation for the reported deflation issue is confirmed, as the balloon was ruptured to be deflated.The investigation for the retraction issue and the investigation for the deflation issue are inconclusive, as the balloon was unable to be tested due to the condition of the device.However, the definitive root cause for the deflation issue, retraction issue, and fiber disturbance 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 cq75124 pta balloon dilatation catheter allegedly experienced a deflation issue, frayed material, and retraction problems.One patient was involved and 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 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8808309
• MDR Text Key: 151647729
• Report Number: 2020394-2019-01622
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741063251
• UDI-Public: (01)00801741063251
• 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: CQ75124
• Device Catalogue Number: CQ75124
• Device Lot Number: RECW1150
• Date Manufacturer Received: 06/30/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1