BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCUTRAK PTA BALLOON DILATATION CATHETER

    MDR report key: 2070287 · Received April 18, 2011

    Report

    Report Number
    2020394-2011-00089
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082343
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE SAMPLE HAS BEEN RECEIVED AND IS BEING EVALUATED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOON WAS DIFFICULT TO DEFLATE AFTER BEING USED IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY AND FOR RESTENOSIS WITHIN A STENT. REPORTEDLY, THE BALLOON WAS INFLATED ONCE IN THE SFA AND THEN INFLATED ONCE WITHIN A STENT AND THEN COULD NOT DE DEFLATED. SEVERAL ATTEMPTS WERE MADE TO DEFLATE THE BALLOON. AFTER APPROX TEN MINS, THE PHYSICIAN STRAIGHTENED THE CATHETER SHAFT AND REPOSITIONED THE BALLOON AND APPLIED NEGATIVE PRESSURE AGAIN. THE BALLOON WAS SUCCESSFULLY DEFLATED. THE BALLOON CATHETER WAS REMOVED THROUGH THE INTRODUCER SHEATH WITHOUT INCIDENT. FINAL ANGIOGRAPHY SHOWED A COMPLETE OCCLUSION OF THE LOWER LEG; THEREFORE, A THROMBECTOMY WAS PERFORMED, SUCCESSFULLY RESTORING FLOW TO THE LOWER EXTREMITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCUTRAK PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. GFUJ3041

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention