BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORADO PTA BALLOON DILATATION CATHETER

    MDR report key: 2030373 · Received March 22, 2011

    Report

    Report Number
    2020394-2011-00055
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K072283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS FOR THE DEVICE HAVE BEEN REVIEWED. THE LOT MET ALL RELEASE CRITERIA AND NO ISSUES WERE NOTED DURING THE MFG PROCESS OR QUALITY CONTROL INSPECTIONS. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS LOT NUMBER. THE BALLOON CATHETER HAS BEEN RETURNED AND IS CURRENTLY BEING EVALUATED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DIFFICULTY RETRACTING THE PTA BALLOON DILATATION CATHETER THROUGH THE INTRODUCER SHEATH AND THE BALLOON SEPARATED FROM THE CATHETER. REPORTEDLY, THE BALLOON GOT STUCK IN THE SHEATH AND SEPARATED FROM THE CATHETER AND WAS REMOVED TOGETHER WITH THE SHEATH AS A SINGLE UNIT. ANOTHER SHEATH AND BALLOON CATHETER WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORADO PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. 93KU0155

    Patients

    Seq Age Sex Outcome Treatment
    1