BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCUTRAK 2 PTA BALLOON DILATATION CATHETER

    MDR report key: 2024014 · Received March 14, 2011

    Report

    Report Number
    2020394-2011-00045
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Report Date
    February 17, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED. THIS LOT MET ALL RELEASE CRITERIA. THERE IS NOTHING SEEN IN THE DHR TO INDICATE THAT THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS CORPORATE LOT NUMBER. 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 COULD NOT BE DEFLATED AFTER TREATING A STENOSIS IN THE SFA-POPLITEAL ARTERY. REPORTEDLY, THE BALLOON WAS INFLATED AND DEFLATED ONCE AND THEN REPOSITIONED AND REINFLATED BUT THEN COULD NOT BE DEFLATED. THE BALLOON WAS DEFLATED BY A NEEDLE PUNCTURE THROUGH THE SKIN AND REMOVED THROUGH THE SHEATH. THE PROCEDURE ENDED WITHOUT FURTHER TREATMENT AS THE STENOSIS WAS RESOLVED ON THE SECOND INFLATION. THERE WAS NO REPORT OF INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCUTRAK 2 PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. GFUI4008

    Patients

    Seq Age Sex Outcome Treatment
    1