BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORADO PTA BALLOON DILATATION CATHETER

    MDR report key: 1130461 · Received August 20, 2008

    Report

    Report Number
    2020394-2008-00234
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    July 30, 2008
    Report Date
    July 31, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    LIT
    PMA / PMN Number
    K072283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS UNK. THE SAMPLE HAS NOT BEEN RETURNED FOR EVAL AS IT WAS DISCARDED AT THE USER FACILITY. BASED ON THE INFO RECEIVED, THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AND THE ROOT CAUSE IS UNK. THE CURRENT IFU STATES: WHILE MAINTAINING NEGATIVE PRESSURE AND THE POSITION OF THE GUIDEWIRE, WITHDRAW THE DEFLATED DILATATION CATHETER OVER THE WIRE THROUGH THE INTRODUCER SHEATH. USE OF A GENTLE COUNTERCLOCKWISE MOTION MAY BE USED TO HELP FACILITATE CATHETER REMOVAL THROUGH THE INTRODUCER SHEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN WAS USING A PTA BALLOON TO POST DILATE THREE COVERED STENT GRAFTS, IN AN ARTERIAL CASE IN THE SFA. HE WAS TAKING AN UP AND OVER CONTRALATERAL APPROACH. USING AN INFLATION DEVICE HE INFLATED THE BALLOON SEVERAL TIMES. ON THE FINAL INFLATION, IT TOOK A LONG TIME TO DEFLATE, SO HE REMOVED THE INFLATION DEVICE AND ATTACHED A 10CC SYRINGE TO REMOVE THE REMAINDER OF THE CONTRAST. ASSUMING THAT IT WAS FULLY DEFLATED, HE STARTED TO RETRACT THE BALLOON. AS HE WAS PULLING BACK, IT ALLEGEDLY MOVED ALL THE STENT GRAFTS, BECAUSE IT PANCAKED (FLATTENED) OUT CATCHING ON THE MARKERS INSIDE THE STENT GRAFTS. UPON REMOVAL, HE COULD SEE A TEAR IN THE BALLOON, FROM THE STENT GRAFTS. HE DEPLOYED ANOTHER STENT GRAFT TO ENSURE MAXIMUM COVERAGE, DISRUPTED BY THE BALLOON. NO PT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1