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

Model Number VA80104

Device Problems Deflation Problem (1149); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the reported event, the device return to bd is pending.The photo review is currently underway review.The company is still investigating the issue at this time.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model va80104 pta balloon dilatation catheter allegedly experienced deflation problem and retraction problem.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 for the device was provided; therefore, a lot history review was performed.The device was not returned to the manufacturer for evaluation; however, a photo was provided.The investigation is inconclusive for deflation and retraction issue.The 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 va80104 pta balloon dilatation catheter allegedly experienced deflation problem and retraction problem.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: 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: 9962529
• MDR Text Key: 187720305
• Report Number: 2020394-2020-02681
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741121258
• UDI-Public: (01)00801741121258
• 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: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: VA80104
• Device Catalogue Number: VA80104
• Device Lot Number: 93NE0032
• Date Manufacturer Received: 06/26/2020
• Patient Sequence Number: 1