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

Model Number U4150530RX

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the malfunction was provided and a lot history review was performed.The device has not been returned for evaluation; therefore, the investigation is inconclusive for the material deformation as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model u4150530rx pta balloon dilatation catheter allegedly experienced material deformation.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient was a 78 year old male; weight was 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: 9963339
• MDR Text Key: 189158312
• Report Number: 2020394-2020-02695
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741058035
• UDI-Public: (01)00801741058035
• 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: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: U4150530RX
• Device Catalogue Number: U4150530RX
• Device Lot Number: CMCY0427
• Date Manufacturer Received: 03/31/2020
• Type of Device Usage: N
• Patient Sequence Number: 1