MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA CATHETER; PTA BALLOON DILATATION CATHETER

Model Number U357584

Device Problems Difficult to Insert (1316); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the reported complaint, the devices were returned to bd.The company is still investigating the issue at this time.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model u357584.Pta balloon dilatation catheter allegedly experienced retraction problem and difficult to insert.This report was received from a single source.This event did involve patient with no reported patient injury.The patients age, weight and gender were not provided.

Manufacturer Narrative

H10: the lot number was provided and a lot history review was performed.The device was returned and the investigation is confirmed for the retraction issue, but inconclusive for the reported insertion difficulty.A definitive root cause could not be established.The device is labeled for single use.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model u357584.Pta balloon dilatation catheter allegedly experienced retraction problem and difficult to insert.This report was received from a single source.This event did involve patient with no reported patient injury.The patients age, weight and gender were not provided.

• Brand Name: ULTRAVERSE 035 PTA CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9199603
• MDR Text Key: 162622648
• Report Number: 2020394-2019-04023
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741093951
• UDI-Public: (01)00801741093951
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: U357584
• Device Catalogue Number: U357584
• Device Lot Number: CMCY0147
• Date Manufacturer Received: 12/31/2019
• Patient Sequence Number: 1