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

Model Number CQF7564

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Of the two malfunctions, two lot numbers were provided, and lot history reviews were performed.A device was returned for evaluation for each malfunction; the evaluation did not identify a deflation issue.A root cause has not been determined.The devices were labeled for single use.

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that model cqf7564 pta balloon dilatation catheter allegedly experienced deflation issue.This information was received from various sources.Each malfunctions involved a patient with no known impact to the patient.One patient was a (b)(6) year-old female weighing (b)(6) lb and the other patient was a (b)(6) year-old female weighing (b)(6) lb.

• 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: 9596525
• MDR Text Key: 178322735
• Report Number: 2020394-2020-00456
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060441
• UDI-Public: (01)00801741060441
• 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

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CQF7564
• Device Catalogue Number: CQF7564
• Device Lot Number: REBW0190, RECV3055
• Date Manufacturer Received: 12/31/2019
• Type of Device Usage: N
• Patient Sequence Number: 1