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

Model Number	VA8084
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a lot history review will be performed.The sample was not returned to the manufacturer for inspection/evaluation; however, the photo was provided for review.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model va8084 pta balloon dilatation catheter allegedly experienced deflation problem and difficult to remove.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The age, weight and gender of the patient were not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model va8084 pta balloon dilatation catheter allegedly experienced deflation problem and difficult to remove.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The age, weight and gender of the patient were not provided.
Additional 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, two electronic photos were provided for review.The investigating is confirmed for difficult to remove; however, the investigation is inconclusive for deflation issues.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
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10730977
• Report Number: 2020394-2020-06029
• Device Sequence Number: 16909285
• Product Code: LIT
• UDI-Device Identifier: 00801741121333
• UDI-Public: (01)00801741121333
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2021

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
• Operator of Device: No Information
• Device Model Number: VA8084
• Device Catalogue Number: VA8084
• Device Lot Number: 93XD0012
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 01/07/2021
• Patient Sequence Number: 1