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

Model Number CQF75108

Device Problems Entrapment of Device (1212); Inflation Problem (1310); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.(b)(4).

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model cqf75108 pta dilatation catheter allegedly experienced entrapment of the device, inflation issues, retraction problems, material rupture, failure to advance and foreign material.This information was received from one source.One patient was involved with no patient consequences.The patient was a (b)(6) -year-old female who weighed (b)(6) pounds.

Manufacturer Narrative

A lot history review was conducted, and it was determined that a device history record (dhr) review was not required.The device and a photo were received for evaluation.The investigation was confirmed for longitudinal rupture, inflation issue, material unraveling.A root cause has not been determined.The device is labeled for single use.Device code (1546, 2524).(device code: 1664 unraveled material, 1536 retraction problem; results, conclusion).

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model cqf75108 pta dilatation catheter allegedly experienced entrapment of the device, inflation issues, retraction problems, material rupture, failure to advance and foreign material.This information was received from one source.One patient was involved with no patient consequences.The patient was a 71-year-old female who weighed 166 pounds.

• 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
• MDR Report Key: 8823498
• MDR Text Key: 152100987
• Report Number: 2020394-2019-01823
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741060649
• UDI-Public: (01)00801741060649
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CQF75108
• Device Catalogue Number: CQF75108
• Device Lot Number: RECX4047
• Date Manufacturer Received: 09/30/2019
• Patient Sequence Number: 1