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

Model Number	V1850150
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/19/2019
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 codes 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: 02/2022).
Event or Problem Description
It was reported that during an angioplasty procedure of a slightly calcified lesion in the popliteal artery, the pta balloon allegedly would not deflate.It was further reported that the physician used a needle stick to percutaneously deflate the balloon.A stent was placed at the puncture site.Patency was reportedly restored post procedure.There were no further reported complications.
Event or Problem Description
It was reported that during an angioplasty procedure of a slightly calcified lesion in the popliteal artery, the pta balloon allegedly would not deflate.It was further reported that the physician used a needle stick to percutaneously deflate the balloon.A stent was placed at the puncture site.Patency was reportedly restored post procedure.There were no further reported complications.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a manufacturing review was performed.The sample was returned to the manufacturer for evaluation.A visual inspection was performed and no anomalies were noted to inflation/deflation port or the device.An in house presto inflation device was used to flush the device inflation lumen and water was noted to be leaking from the hole in the balloon caused by the user puncturing the device.No further functional testing was able to be performed.Therefore, the investigation is inconclusive for the reported deflation issue, as no anomalies could be noted to the deflation port, and the device was unable to be functionally tested due to the user puncturing the balloon.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 codes 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.H10: d4: (expiry date: 02/2022), d10, g4.H11: h3, h6 (method, results).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.

• Brand Name: VASCUTRAK 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: 9477166
• Report Number: 2020394-2019-05632
• Device Sequence Number: 11327379
• Product Code: PNO
• UDI-Device Identifier: 00801741061691
• UDI-Public: (01)00801741061691
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 03/02/2020

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: V1850150
• Device Catalogue Number: V1850150
• Device Lot Number: GFDP3791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 03/02/2020
• 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