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

Model Number CQ7584

Device Problems Deflation Problem (1149); Inflation Problem (1310); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device were provided, a lot history review was performed.The sample was returned to the manufacturer for evaluation.The investigation was unconfirmed for the reported inflation issue, deflation issue and twisted inflation port.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that the model cq7584 pta balloon dilatation catheter allegedly had an material twisting, inflation issue, and unable to deflate.This information was received from one source.The malfunction involved patient with no known impact to the patient.The patient was (b)(6) years old male, weighed (b)(6) lbs.

• 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 ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10289552
• MDR Text Key: 199283481
• Report Number: 2020394-2020-04613
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741063114
• UDI-Public: (01)00801741063114
• 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: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CQ7584
• Device Catalogue Number: CQ7584
• Device Lot Number: REDW2877
• Date Manufacturer Received: 06/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1