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

Model Number AT75144

Device Problems Material Frayed (1262); Material Rupture (1546); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Malfunction  

Manufacturer Narrative

The lot number for the device was provided, therefore a lot history review was performed. The device was returned and is confirmed for fiber disturbance and catheter shaft tears. The investigation is inconclusive for rupture. The definitive root cause is unknown. The device is labeled for single use.

Event Description

This report summarizes one malfunction. A review of the information indicates that model at75144 experienced frayed material, rupture, and split material. The information was received from one source. The malfunction involved a patient with no reported patient injury. The patient's age, weight, and gender were 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: 9588956
• MDR Text Key: 180119635
• Report Number: 2020394-2020-00261
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/14/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 01/14/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: NO INFORMATION
• Device MODEL Number: AT75144
• Device Catalogue Number: AT75144
• Device LOT Number: GFDU2287
• Was Device Available For Evaluation?: No Answer Provided

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/31/2019
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No Answer Provided

Is this a Reprocessed and Reused Single-Use Device?

Type of Device Usage