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

Model Number	VA80104
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 return of the device is pending.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction.A review of the information indicates that model va80104 pta dilatation catheter allegedly experienced a retraction problem.The information came from one source.The malfunction involved a patient with no reported patient injury.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 was returned for the evaluation.The investigation is confirmed for the reported retraction problem, as the introducer sheath was noted to be buckled and bunched.The definitive root cause for the reported retraction problem could not be determined based upon available information.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 or Problem Description
This report summarizes one malfunction.A review of the information indicates that model va80104 pta dilatation catheter allegedly experienced a retraction problem.The information came from one source.The malfunction involved a patient with no reported patient injury.The patient's age, weight, and gender were not provided.

• 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: 9953765
• Report Number: 2020394-2020-02633
• Device Sequence Number: 2789769
• Product Code: DQY
• UDI-Device Identifier: 00801741121258
• UDI-Public: (01)00801741121258
• 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): 07/06/2020

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: VA80104
• Device Catalogue Number: VA80104
• Device Lot Number: 93ZD0072
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 07/06/2020
• Patient Sequence Number: 1