BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATB ADVANCE BALLOON CATHETER

    MDR report key: 3122528 · Received May 16, 2013

    Report

    Report Number
    1820334-2013-00204
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 22, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DQY
    PMA / PMN Number
    K033875
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REMOVAL OF FOREIGN BODY IS NOT LISTED IN THE INSTRUCTIONS FOR USE. BALLOON RUPTURE IS LISTED IN THE INSTRUCTIONS FOR USE. INVESTIGATION EVAL: PRODUCT WAS RETURNED IN A USED AND DAMAGED CONDITION INCLUDING THE SEPARATED SEGMENT. BALLOON BURST, COMPLIANCE, AND FATIGUE VERIFICATION TESTING HAS BEEN COMPLETED. THE RATED BURST PRESSURE IS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU) AND LABEL. THE DEVICE IS INSPECTED TO ENSURE BALLOON IS UNDAMAGED. EACH DEVICE IS SHIPPED WITH AN IFU THAT DELINEATES THE PROPER INFLATION AND DEFLATION PROCEDURES. THE IFU STATES "DO NOT EXCEED THE RATED BURST PRESSURE. RUPTURE MAY OCCUR. ADHERE TO BALLOON INFLATION PRESSURE PARAMETERS." AN EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE COMPLAINT DESCRIPTION OF SEPARATION. NO EVIDENCE OF A LONGITUDINAL TEAR IN EITHER THE PROXIMAL OR DISTAL PORTION. ALTHOUGH IT SHOULD BE NOTED THE DISTAL PORTION IS HEAVILY DAMAGED. IN THE ABSENCE OF EXTERNAL RESTRAINTS THE BALLOON IS DESIGNED TO BURST IN A LONGITUDINAL DIRECTION. WHEN SUFFICIENTLY CONSTRICTED BY, FOR EXAMPLE THE LESSONS OR OTHER TORTUROUS ANATOMY THE TEAR MAY GO CIRCUMFERENTIAL. AFTER RUPTURE THE DISTAL PORTION WILL "UMBRELLA", AS DESCRIBED IN THE EVENT, WHEN ATTEMPTING TO RESHEATH CAUSING THE BALLOON TO SEPARATE. THE EXACT CAUSE OF THE ORIGINAL RUPTURE CANNOT BE DETERMINED. INFLATION PRESSURE IS STATED AS 14ATM, THE ATB5 USED IN THIS COMPLAINT HAS A RATED BURST PRESSURE OF 15ATM. THE EVENT DESCRIPTION STATES THE DEVICE "WENT INTO THE ARM AND THROUGH PREVIOUSLY IMPLANTED STENTS". IT IS POSSIBLE THAT THE DEVICE WAS DAMAGED DURING NAVIGATION TO THE INTENDED SITE. BASED ON THE EXAMINATION OF THE RETURNED DEVICE AND THE DESCRIPTION OF THE EVENT A ROOT CAUSE CANNOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THERE IS INSUFFICIENT RISK PER QUALITY ENGINEERING RISK ASSESSMENT TO WARRANT ADDITIONAL RISK REDUCTION ACTIVITIES.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PHYSICIAN WAS REPAIRING A LEFT ARM FISTULA. THE PHYSICIAN WENT INTO THE ARM AND THROUGH PREVIOUSLY IMPLANTED STENTS. THE PHYSICIAN ADVANCED THE BALLOON CATHETER A LITTLE FORWARD AND AS HE PULLED BACK AGAIN, HALF OF THE PROXIMAL PIECE OF THE BALLOON AND THE BALLOON CATHETER STAYED IN THE PT AND THE REST CAME OUT. THE PHYSICIAN SNARED THE REMAINING PIECES OF THE BALLOON, BUT COULD NOT GET THE SNARE AND THE BALLOON PIECE OUT OF THE PT. THE BALLOON WAS SNARED IN THE FISTULA. PHYSICIAN ATTEMPTED TO PULL, BUT COULD NOT GET IT OUT. THE PHYSICIAN CALLED IN VASCULAR SURGERY TO PERFORM A CUT DOWN TO REMOVE THE BALLOON. WHEN THE SURGEON CUT THE SKIN DOWN TO THE VESSEL, THEY COULD SEE THE BLACK PIECE OF THE BALLOON CATHETER. THEY ELECTED TO TAKE HEMOSTATS AND GRAB THE BLACK PIECE AND PULL THE BALLOON AND BALLOON CATHETER OUT OF THE PT. THE PT'S BLOOD PRESSURE DROPPED DURING THE PROCEDURE. AFTER THE DEVICE WAS RETRIEVED AND EVERYTHING PULLED OUT OF THE PT, THE PT STABILIZED. THE PHYSICIAN ANGIOPLASTIED THE FISTULA AND THE BALLOON RUPTURED AT 14 ATM. WHILE ATTEMPTING TO PULL THE BALLOON BACK THROUGH THE SHEATH (THE DISTAL PORTION OF THE BALLOON WAS IN THE SHEATH) A LITTLE RESISTANCE WAS FELT. AS THE PHYSICIAN CONTINUED TO PULL BACK (WITH RESISTANCE). IT SEEMED A LITTLE TIGHTER, BUT IT WAS NOT WHERE THE PHYSICIAN FELT LIKE THERE WAS A PROBLEM. AT THAT POINT, UNDER FLUORO, THE PHYSICIAN SAW THE PROXIMAL PIECE OF THE BALLOON AND THE BALLOON CATHETER. THE BALLOON LOOKED LIKE AN "UMBRELLA" OVER THE SHEATH. THE PHYSICIAN TRIED TO TAKE THE SHEATH OUT AS HE WANTED TO INSERT A BIGGER SHEATH, BUT REALIZED HE COULD NOT ACHIEVE THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216869 ATB ADVANCE BALLOON CATHETER DQY CATHETER, PERCUTANEOUS DQY COOK, INC. NA 4039632

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention