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

Model Number VA8088

Device Problems Deflation Problem (1149); Retraction Problem (1536); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the malfunction was provided; therefore, a lot history review is currently being performed.The device was returned for 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 va8088 pta balloon dilatation catheter allegedly experienced deflation problem, retraction issue and material rupture.This report was received from one source.This malfunction involved one patient with no patient consequences.Age, weight, and gender were not provided.

Manufacturer Narrative

H10: 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.Therefore, the investigation is confirmed for deflation problem, retraction issue and material rupture.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H11: h6 (results, conclusion).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 va8088 pta balloon dilatation catheter allegedly experienced deflation problem, retraction issue and material rupture.This report was received from one source.This malfunction involved one patient with no patient consequences.Age, weight, and gender were not provided.

• Brand Name: VACCESS PTA DILATION CATHETER
• Type of Device: PTA BALLOON DILATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10300303
• MDR Text Key: 199658701
• Report Number: 2020394-2020-04682
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741059971
• UDI-Public: (01)00801741059971
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: VA8088
• Device Catalogue Number: VA8088
• Device Lot Number: 93PE0110
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 10/15/2020
• Patient Sequence Number: 1