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

Model Number	VA8086
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number has been provided and a lot history review will be performed.The sample has been returned for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model va8086, pta balloon dilatation catheter, allegedly experienced a retraction problem.This information was received from a single source.This malfunction involved a patient with no consequences.The patient's age, weight, and gender were not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model va8086, pta balloon dilatation catheter, allegedly experienced a retraction problem.This information was recieved from a single source.This malfunction invovled a patient with no consequences.The patient's age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation confirmed 1536 - retraction problem.Based upon the available information, a definitive root cause 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: 9586746
• Report Number: 2020394-2020-00204
• Device Sequence Number: 2473754
• Product Code: DQY
• UDI-Device Identifier: 00801741121340
• UDI-Public: (01)00801741121340
• 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): 04/02/2020

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
• Operator of Device: No Information
• Device Model Number: VA8086
• Device Catalogue Number: VA8086
• Device Lot Number: 93UD0024
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 04/02/2020
• Patient Sequence Number: 1