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

Model Number	V1850200
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be 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 is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiry date: (4/28/2022).
Event or Problem Description
It was reported that during an angioplasty procedure in femoral artery, the pta balloon allegedly unable to deflate.The procedure was completed by using a needle stick to deflate the balloon.The current status of the patient is unknown.

• Brand Name: VASCUTRACK 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: 10474934
• Report Number: 2020394-2020-05539
• Device Sequence Number: 11299418
• Product Code: PNO
• UDI-Device Identifier: 00801741061707
• UDI-Public: (01)00801741061707
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: V1850200
• Device Catalogue Number: V1850200
• Device Lot Number: GFDR3283
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2020
• Initial Report FDA Received Date: 08/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR