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

Model Number	V143040
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.(expiry date: 09/2023).
Event or Problem Description
It was reported that during an angioplasty procedure at the lower leg, the catheter of the pta balloon allegedly broke.The physician was unable to snare out the broken piece from the patient.The current patient status is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one vascutrak pta dilatation catheter has returned for evaluation.On the visual evaluation of the device, it appeared bloody, no specific anomalies noted on the device.No wire detachment or breaks were noted under microscopic evaluation.The manufacturing site performed an additional review of the returned sample, and no evidence of break or detachment of the wire were noted on the device.One image was reviewed.A report describes an event in which a guidewire associated with an angioplasty balloon fractured and was unable to removed.The image provided cannot confirm this.If possible, other images from the below the knee should be provided to further evaluate and should include the wire in question.Wire fractures are quite rare but can be due to the wire being stuck in a subintimal plane or structural failure of the wire.Ideally, the fractured wire should be removed if feasible because this could theoretically result in an increased thrombotic risk.However, there are reports of cases where the wire could not be removed via endovascular techniques and was therefore left within the patient without harm.Therefore, based on the image review, the reported wire break, detachment and retraction issue remains inconclusive, since no evidence noted on the submitted image.Therefore, the investigation for the reported wire break, detachment and removal issue are unconfirmed, as no evidence of a break or detachment of the device component were noted.A definitive root cause for the reported wire break, detachment and removal issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: b5, d4 (expiry date: 09/2023), g3, h6 (device, method).H11: h6 (result, conclusion).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 at the lower leg, the guidewire of the pta balloon allegedly detached.It was further reported that the device allegedly was broken and it was difficult to remove.Physician was unable to snare out the broken piece from the patient.The current patient status is unknown.

• 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: 11775542
• Report Number: 2020394-2021-00970
• Device Sequence Number: 19617328
• Product Code: PNO
• UDI-Device Identifier: 00801741061318
• UDI-Public: (01)00801741061318
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 09/23/2021

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: V143040
• Device Catalogue Number: V143040
• Device Lot Number: GFEW0791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 10/04/2021
• 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