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

Model Number U4150415RX

Device Problems Failure to Advance (2524); Device-Device Incompatibility (2919); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the malfunction was not provided; therefore, a lot history will not be performed.The device was returned, and was confirmed for material deformation and device-device incompatibility; however, inconclusive for failure to advance.Based upon the available information, the definitive root cause for this event is unknown.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model u4150415rx pta balloon dilatation catheter allegedly experienced failure to advance and material deformation.This information was received from one source.The event involved a patient with no known impact to the patient.The patient 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: 9592010
• MDR Text Key: 179313371
• Report Number: 2020394-2020-00309
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741057618
• UDI-Public: (01)00801741057618
• 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: 01/15/2020

1 Device was Involved in the Event

1 Patient was 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: U4150415RX
• Device Catalogue Number: U4150415RX
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/31/2019
• Type of Device Usage: N
• Patient Sequence Number: 1