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

Model Number U415034RX

Device Problems Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was not returned to the manufacturer for evaluation.Therefore, the investigation is inconclusive for the reported failure to advance, and material deformation issue.The definitive root cause could not be determined based upon available information.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicates the model u415034rx pta balloon dilatation catheter allegedly experienced material deformation, and failure to advance.The report was received from a single source.This malfunction involved patient with no known impact to the patient.The patient's age, gender, and 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: 10738913
• MDR Text Key: 213174688
• Report Number: 2020394-2020-06134
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741056802
• UDI-Public: (01)00801741056802
• 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: 10/27/2020

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: U415034RX
• Device Catalogue Number: U415034RX
• Device Lot Number: CMEN0567
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/27/2020
• Type of Device Usage: N
• Patient Sequence Number: 1