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

Model Number U4150215RX

Device Problems Crack (1135); Inflation Problem (1310); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Malfunction  

Manufacturer Narrative

The lot number was provided and a lot history review will be performed. The sample was returned for evaluation. Inflation issues, material deformation, and detachment were identified during the evaluation. The root cause could not be determined. The device was labeled for single use.

Event Description

This report summarizes one malfunction. A review of the reported information indicated that model u4150215rx, pta dilatation catheter, allegedly experienced an inflation issue. This information was received from a single source. This malfunction involved a patient with no consequences. The patient's age, weight, and gender were not provided.

• Brand Name: ULTRAVERSE RX 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): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9593729
• MDR Text Key: 179401782
• Report Number: 2020394-2020-00374
• 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,Followup
• Report Date: 04/02/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 01/15/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: NO INFORMATION
• Device MODEL Number: U4150215RX
• Device Catalogue Number: U4150215RX
• Device LOT Number: CMCV0466
• Was Device Available For Evaluation?: No Answer Provided
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/25/2020
• 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