BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATB ADVANCE BALLOON CATHETER

    MDR report key: 2915522 · Received January 9, 2013

    Report

    Report Number
    1820334-2013-00042
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    COOK, INC.
    Product Code
    DQY
    PMA / PMN Number
    K033875
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WAS RETURNED; BUT TWO PHOTOS WERE SENT TO ASSIST IN THIS INVESTIGATION. BALLOON BURST, COMPLIANCE, AND FATIGUE VERIFICATION TESTING PERFORMED. THE DEVICE IS INSPECTED TO ENSURE BALLOON IS UNDAMAGED. VENDOR BURST TESTS A MINIMUM OF 10 BALLOONS PER LOT. EACH DEVICE IS LEAK TESTED AND THE BALLOON BONDS ARE EXAMINED. EACH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) THAT DELINEATES THE PROPER INFLATION AND DEFLATION PROCEDURES. THESE DETECTION ACTIVITIES WILL LIKELY RESULT IN A VERY HIGH PROBABILITY OF DETECTION TO PREVENT RUPTURE. THE RATED BURST PRESSURE, RBP, IS DOCUMENTED IN THE IFU AND LABEL. WITHOUT THE COMPLAINT DEVICE A THOROUGH ROOT CAUSE ANALYSIS IS NOT POSSIBLE. THE EVENT DESCRIPTION DOES NOT STATE IF IT WAS SUSPECTED THAT THE BALLOON RUPTURE OR SUFFERED SOME OTHER DAMAGE. INFLATION PRESSURES WERE NOT PROVIDED NOR WAS A DESCRIPTION OF PT ANATOMY OTHER THAN "END STAGE RENAL DISEASE - FISTULA" WHICH COULD CONTRIBUTE TO DEVICE FAILURE. DEVICE RUPTURE RESULTED IN DIFFICULTY WITHDRAWING AND REMOVAL. IN THE ABSENCE OF COMPLAINT DETAIL IT IS DIFFICULT TO DETERMINE FACTORS OTHER THAN PT ANATOMY THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT. DUE TO THIS ABSENCE OF DETAIL THE ROOT CAUSE FOR THIS COMPLAINT IS INCONCLUSIVE. AN EXAMINATION OF THE PHOTOS SHOWS THE PROXIMAL PORTION OF THE BALLOON AND IN THE SECOND PHOTO THE DISTAL PORTION STRIPPED OF THE BALLOON. IT CANNOT BE SEEN IN THE PHOTO IF THE RUPTURE ORIGINATED LONGITUDINALLY OR CIRCUMFERENTIAL. IN THE ABSENCE OF EXTERNAL RESTRAINTS THE BALLOON IS DESIGNED TO BURST IN A LONGITUDINAL DIRECTION. WHEN SUFFICIENTLY CONSTRICTED BY, FOR EXAMPLE A "CALCIFIED LESION" THE TEAR MAY GO CIRCUMFERENTIAL. AFTER RUPTURE THE DISTAL PORTION WILL "UMBRELLA" WHEN ATTEMPTING TO RESHEATH CAUSING THE BALLOON TO SEPARATE. THERE HAS BEEN NO INCREASE IN COMPLAINTS CONCERNING THE ATB BALLOON. IN THE ABSENCE OF COMPLAINT DETAIL IT IS DIFFICULT TO DETERMINE FACTORS OTHER THAN PT ANATOMY THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT. DUE TO THIS ABSENCE OF DETAIL THE ROOT CAUSE FOR THIS COMPLAINT IS INCONCLUSIVE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    PER CUSTOMER "WE HAD A TERRIBLE PROBLEM THAT HAPPENED TODAY WITH THE 12 X 4 ADVANCE BALLOONS. THE ADVANCE BALLOON BROKE OFF INTO A PT AND IT TOOK THE PHYSICIAN 6 HOURS TO TRY TO FISH IT OUT. THEY WERE UNABLE TO GET ALL OF THE DEBRIS; WHICH LED THEM TO PLACE 5 STENTS IN THE SUBCLAVIAN TO PUSH THE DEBRIS AGAINST THE WALL." PER COMPLAINT FORM "WHILE PLASTYING THE SUBCLAVIAN WITH A 12 X 4 ATB BALLOON, THE BALLOON RUPTURED AND PART OF THE BALLOON SEPARATED FROM THE CATHETER AND NEEDED TO BE FISHED OUT. A PART WAS LEFT INSIDE. A SNARE WAS USED TO RETRIEVE THE PART OF THE BALLOON INSIDE THE VESSEL. THE PHYSICIAN NEEDED TO PLACE A STENT IN THE PATH. THE COMPLAINT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12366 ATB ADVANCE BALLOON CATHETER DQY CATHETER, PERCUTANEOUS DQY COOK, INC. NA 3767113

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention