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

Model Number VA8094

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, lot number was not provided, therefore lot history review could not be performed.The sample 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 indicates that model va8094 pta balloon dilatation catheter allegedly experienced retraction and deflation problem.The information was received from one source.One patient was involved with no reported patient injury.The female patient is (b)(6) years old and weight not provided.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model va8094 pta balloon dilatation catheter allegedly experienced retraction and deflation problem.The information was received from one source.One patient was involved with no reported patient injury.The female patient is 71 years old and weight not provided.

Manufacturer Narrative

H10: for the reported event, lot number was not provided, therefore lot history review was not performed.The sample was returned for evaluation.The investigating is unconfirmed for retraction problem and deflation 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.

• 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: 10287037
• MDR Text Key: 199253525
• Report Number: 2020394-2020-04573
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741121357
• UDI-Public: (01)00801741121357
• 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: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: VA8094
• Device Catalogue Number: VA8094
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 09/30/2020
• Patient Sequence Number: 1