BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXFORCE?

    MDR report key: 3140652 · Received May 31, 2013

    Report

    Report Number
    3005099803-2013-04541
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K910931
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF BALLOON DEFLATION FAILED. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2013-04548 ADDRESSES THE ENCORE INFLATION DEVICE, WHILE MANUFACTURER REPORT # 3005099803-2013-04541 ADDRESSES THE MAXFORCE BALLOON. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 THAT AN ENCORE INFLATION DEVICE AND A MAXFORCE BALLOON WERE USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT (CBD) ON (B)(6) 2013. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE MAXFORCE BALLOON WAS INSERTED INTO THE CBD TO DILATE THE DUCT. WHEN THE MAXFORCE BALLOON EXITED THE SCOPE THE BALLOON CATHETER KINKED; HOWEVER THEY WERE ABLE TO STILL DILATE THE DUCT. WHEN DEFLATION WAS ATTEMPTED, IT WAS NOTED THAT HE BALLOON WOULD NOT FULLY DEFLATE WITH THE ENCORE DEVICE. THE ENDOSCOPE WAS REMOVED FOR THE PATIENT WITH THE DEVICE, AND THE CATHETER WAS CUT. IT WAS REPORTED THAT IT IS UNKNOWN IF THE DEFLATION ISSUE WAS CAUSED BY THE MAXFORCE BALLOON OR THE ENCORE INFLATION DEVICE. THE DILATATION WAS SUCCESSFUL IN THAT THE STONES WERE ABLE TO FALL OUT OF THE CBD. THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THE PATIENT¿S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240701 MAXFORCE? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00567420 14959090

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR