BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXFORCE TTS BALLOON DILATATION CATHETER

    MDR report key: 1190751 · Received October 6, 2008

    Report

    Report Number
    3005099803-2008-05078
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD.
    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

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISCARDED. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE REPORTED LOT REVEALED NO ANOMALIES. A REVIEW OF THE COMPLAINT DATABASE REVEALED THAT NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED FOR THIS LOT.

    Description of Event or Problem · 1

    NOTE: THIS MFR REPORT PERTAINS TO THE FIRST OF TWO EVENTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MFR REPORT #3005099803-2008-05072 FOR A DESCRIPTION OF THE SECOND EVENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008 THAT A MAXFORCE TTS BALLOON DILATATION CATHETER WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN 2008 (MALE; PT WEIGHT UNK). ACCORDING TO THE COMPLAINANT, "DESPITE BEING ABLE TO COMPRESS THE SYRINGE, THE BALLOON WOULD NOT INFLATE. UNABLE TO CONFIRM IF BALLOON BURST, RUPTURED, OR HAD PINHOLE AS DEVICE WAS DISCARDED." THE PROCEDURE WAS COMPLETED WITH A SECOND MAXFORCE TTS BALLOON DILATATION CATHETER DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXFORCE TTS BALLOON DILATATION CATHETER FGE BOSTON SCIENTIFIC IRELAND, LTD. M00567420 11718064

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR