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

Model Number	VA8064
Medical Device Problem Code	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, therefore, a lot history review was performed.The sample was returned for evaluation and the investigation confirmed for the reported rupture issue.The definitive root cause could not be determined.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 va8064 pta balloon dilatation catheter allegedly experienced a rupture.The information was received from a single source.One patient was involved with no reported patient injury.The female patient is (b)(6) years old and weighs (b)(6) kgs.
Additional Manufacturer Narrative
H10: for the reported malfunction, reportability was reassessed and determined to be no longer reportable.H10: the lot number was provided, therefore, a lot history review was performed.The sample was returned for evaluation and the investigation confirmed for the reported rupture issue.The definitive root cause could not be determined.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 reported information indicated that model va8064 pta balloon dilatation catheter allegedly experienced a rupture.The information was received from a single source.One patient was involved with no reported patient injury.The female patient is 62 years old and weighs 51 kgs.

• 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: 10760161
• Report Number: 2020394-2020-06343
• Device Sequence Number: 16977583
• Product Code: DQY
• UDI-Device Identifier: 00801741121296
• UDI-Public: (01)00801741121296
• 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): 01/14/2021

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: VA8064
• Device Catalogue Number: VA8064
• Device Lot Number: 93YD0175
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 01/14/2021
• Patient Sequence Number: 1