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

Model Number VA80124

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 was performed.The sample was returned to the manufacturer for inspection/evaluation.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 va80124 pta dilatation catheter allegedly experienced packaging problem.This information was received from one source.The malfunction involves no reported patient contact.

Manufacturer Narrative

H10: the lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was returned to the manufacturer for evaluation.The investigation is inconclusive for the reported packaging problem.A definitive root cause could not be determined.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 va80124 pta dilatation catheter allegedly experienced packaging problem.This information was received from one source.The malfunction involves no reported patient contact.The patient's age, weight and gender were not provided.

• Brand Name: VACCESS 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: 10730915
• MDR Text Key: 212986705
• Report Number: 2020394-2020-06028
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741121265
• UDI-Public: (01)00801741121265
• 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: 10/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: VA80124
• Device Catalogue Number: VA80124
• Device Lot Number: 93TC0069
• Date Manufacturer Received: 12/31/2020
• Patient Sequence Number: 1