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

Model Number	V1425300
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a lot history will be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 08/2022).
Event or Problem Description
It was reported that during an angioplasty procedure in the lower left extremity, the pta balloon allegedly had deflation issues.A needle stick was used to percutaneously deflate the balloon.Another device was used to complete the procedure.There were no further complications to the patient.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was not required.Investigation summary: the device was returned for evaluation.A visual inspection was performed and no anomalies were noted to the 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 device 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 device.The definitive root cause for the reported deflation issue could not be determined based upon available information.It is unknown whether patient or procedural issues contributed to the event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10.D4 (expiry date: 08/2022).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
It was reported that during an angioplasty procedure in the lower left extremity, the pta balloon allegedly had deflation issues.A needle stick was used to percutaneously deflate the balloon.Another device was used to complete the procedure.There were no further complications to the patient.

• Brand Name: VASCUTRAK PTA BALLOON 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: 9593812
• Report Number: 2020394-2019-05928
• Device Sequence Number: 13576158
• Product Code: PNO
• UDI-Device Identifier: 00801741061288
• UDI-Public: (01)00801741061288
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K103459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2020

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: Health Professional
• Device Model Number: V1425300
• Device Catalogue Number: V1425300
• Device Lot Number: GFDV2802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 05/04/2020
• 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: 64 YR
• Patient Weight: 65