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

Model Number AT75124

Device Problems Material Frayed (1262); Inflation Problem (1310); Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided and a lot history review was performed.The sample was returned and the investigation confirmed for frayed fibers, peeling pebax, unraveled fibers, and uneven inflation.The definitive root cause could not be established.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 at75124 pta balloon dilatation catheter allegedly experienced material frayed, inflation issues, peeled layer, and unraveled material.This information was received from one source.One patient was involved and there was no reported patient injury.Patient information was not provided.

• Brand Name: ATLAS 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): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9194970
• MDR Text Key: 162448697
• Report Number: 2020394-2019-03971
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741062407
• UDI-Public: (01)00801741062407
• 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: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AT75124
• Device Catalogue Number: AT75124
• Device Lot Number: GFDQ0435
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/15/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1