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

Model Number	VA8076
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided for the malfunction and a lot history review was performed.The device was returned for evaluation.The investigation identified a break.A root cause could not be determined.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.The information reviewed indicated that model va8076 pta balloon dilatation catheter allegedly experienced material rupture and break.The information was received from one source.The malfunction involved a patient with no reported consequences.No patient information was provided.
Additional Manufacturer Narrative
H10: the lot number was provided for the malfunction and a lot history review was performed.The device was returned for investigation.The investigation confirmed for retraction issue, balloon joint break and inconclusive for balloon rupture.A definitive root cause could not be determined.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.The information reviewed indicated that model va8076 pta balloon dilatation catheter allegedly experienced material rupture and break.The information was received from one source.The malfunction involved a patient with no reported consequences.No patient information was 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: 9969163
• Report Number: 2020394-2020-02882
• Device Sequence Number: 19953937
• Product Code: DQY
• UDI-Device Identifier: 00801741121326
• UDI-Public: (01)00801741121326
• 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: VA8076
• Device Catalogue Number: VA8076
• Device Lot Number: 93WD0090
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 07/06/2020
• Patient Sequence Number: 1