MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number U4150322

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a lot history review is currently underway.The sample was not returned to the manufacturer for inspection/evaluation however, photos were provided for review.The investigation of the reported malfunction is currently underway.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model u4150322 pta balloon dilatation catheter allegedly experienced packaging problem.This information was received from one source.The one reported malfunction involved one patient with no consequences.The age, sex and weight of the patient was not provided.

Manufacturer Narrative

H10: the lot number for the device was provided and a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation; however, three images were provided for review.The investigating is inconclusive for the reported packaging problem.Based upon the available information, the definitive root cause for this event is unknown.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 u4150322 pta balloon dilatation catheter allegedly experienced packaging problem.This information was received from one source.The one reported malfunction involved one patient with no consequences.The age, sex and weight of the patient were not provided.

• Brand Name: ULTRAVERSE 014 PTA DILATATION 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: 10743898
• MDR Text Key: 213321680
• Report Number: 2020394-2020-06153
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741053832
• UDI-Public: (01)00801741053832
• 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: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: U4150322
• Device Catalogue Number: U4150322
• Device Lot Number: CMEP0312
• Date Manufacturer Received: 12/31/2020
• Patient Sequence Number: 1