BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORADO PTA BALLOON DILATATION CATHETER

    MDR report key: 1053485 · Received May 28, 2008

    Report

    Report Number
    2020394-2008-00147
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Report Date
    May 5, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    LIT
    PMA / PMN Number
    K072283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MFG PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THE SAMPLE WAS RETURNED AND EVALUATED. THE VISUAL EXAMINATION REVEALED NO DAMAGE TO THE CATHETER SHAFT. THE BALLOON REFOLDING TOOL WAS MISSING. IT WAS REPORTED THE PHYSICIAN HAD PULLED A FIBER, WHICH TIED DOWN THE FIBERS, RESULTING IN AN HOURGLASS SHAPE OF THE BALLOON IN THE CENTER OF THE BALLOON. APPROX 6MM DISTAL OF THE TIED DOWN SECTION, THERE WERE NO ROUND FIBERS OR THE OUTER LAYER OF PEBAX, WHICH CREATED THE TIED DOWN SECTION. IT APPEARED THAT ALL ROUND FIBERS WERE PRESENT AND SOME WERE BROKEN. DUE TO DRY CONTRAST MEDIA IN THE INFLATION/DEFLATION LUMENS, UNABLE TO TO INFLATE THE BALLOON. FURTHER PROBING OF THE BALLOON REVEALED SMALL SNAG AREAS DISTALLY IN DIRECTION UP AND DOWN THE BALLOON PROXIMAL AND DISTAL OF THE MAIN SNAG AREA. VISUAL EXAMINATION REVEALED THAT THE BALLOON WAS PROPERLY LAMINATED. VISUAL ANALYSIS OF THE RETURNED UNIT INDICATED THAT THE BALLOON HAD BEEN SNAGGED BY SOME UNK OBJECT DISTALLY IN DIRECTION UP AND DOWN THE BALLOON, PENETRATING THE OUTER LAYER AND FINALLY SNAGGING THE FIBER(S) IN THE CENTER SECTION OF THE BALLOON. SOME UNK OBJECT MAY HAVE CAUSED THE BALLOON DAMAGE. IT SHOULD BE NOTED THAT THE DOCTOR BELIEVED THE BALLOON CAUGHT ON CALCIFIED PLAQUE. NO MFG DEFECT WAS NOTED DURING THE VISUAL EXAMINATION. THE INVESTIGATION CONFIRMED THE COMPLAINT, BUT THE EXACT CAUSE COULD NOT BE DETERMINED. 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 THE BALLOON FIBERS THAT WRAP AROUND THE PTA BALLOON, FELL APART. "FILMS AND RECORD OF THE CASE COULD NOT BE LOCATED. HOWEVER, THE PHYSICIAN VAGUELY REMEMBERS THE DEVICE BEING USED FOR POST DILATATION IN THE EXTERNAL ILIAC AND BELIEVES THAT THE BALLOON CAUGHT ON CALCIFIED PLAQUE. WHEN HE REMOVED THE BALLOON, THE FIBER APPEARED TO BE SLIGHTLY DETACHED FROM THE BALLOON ITSELF. HE THEN LOOKED AT IT WAS PROCEEDED TO PULL THE THREAD. THIS IS ALL THE PHYSICIAN COULD OFFER FOR DETAILS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORADO PTA BALLOON DILATATION CATHETER LIT BARD PERIPHERAL VASCULAR, INC. 93HR0010

    Patients

    Seq Age Sex Outcome Treatment
    1