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

Model Number	V1850200
Medical Device Problem Code	Deflation Problem (1149)
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 reported malfunction; therefore, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event 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 indicates that model v1850200 pta balloon dilatation catheter allegedly experienced deflation problem.The information was received from one source.One patient was involved with no reported patient injury.The female patient was 73 years old and weight not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model v1850200 pta balloon dilatation catheter allegedly experienced deflation problem.The information was received from one source.One patient was involved with no reported patient injury.The female patient was 73 years old and weight not provided.
Additional Manufacturer Narrative
H10: the reported malfunction was reassessed for reportability and determined to be reportable as a serious injury, and was reported under emdr 2020394-2020-05539.H10: the lot number for the reported malfunction was provided, therefore, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event could not be determined.The device is labeled for single use.

• Brand Name: VASCUTRAK PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DIALATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10293427
• Report Number: 2020394-2020-04643
• Device Sequence Number: 2525899
• Product Code: PNO
• UDI-Device Identifier: 00801741061707
• UDI-Public: (01)00801741061707
• 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): 10/19/2020

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: V1850200
• Device Catalogue Number: V1850200
• Device Lot Number: GFDR3283
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/18/2020
• Supplement Report FDA Received Date: 10/19/2020
• Patient Sequence Number: 1