BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROVASIVE RX LOCKING DEVICE

    MDR report key: 1133497 · Received August 22, 2008

    Report

    Report Number
    3005099803-2008-03618
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K010610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS NOT ABLE TO PROVIDE THE LOT NUMBER OF THE SUSPECT DEVICE; THEREFORE, THE DEVICE MANUFACTURE DATE CANNOT BE DETERMINED. THE DETACHED PORTION OF THE DEVICE WAS RETURNED (THE REST OF THE DEVICE WAS NOT RETURNED). VISUAL EXAMINATION OF THE RETURNED SPONGE PORTION OF THE DEVICE REVEALED THAT IT WAS TORN, AND THAT A LARGE PORTION WAS MISSING. THE CAUSE OF THE DAMAGE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT A RX LOCKING DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ABOUT TWO DAYS PRIOR. ACCORDING TO THE COMPLAINANT, WHILE THE PHYSICIAN WAS INSERTING THE SPHINCTEROTOME (MANUFACTURER UNK) INTO THE MICROVASIVE RX LOCKING DEVICE, "THE WHITE COTTON MATERIAL INSIDE CAP DISLODGED INTO THE [ENDO] SCOPE AND WAS DIFFICULT TO REMOVE." THE PROCEDURE WAS COMPLETED WITH A SECOND MICROVASIVE RX LOCKING DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROVASIVE RX LOCKING DEVICE KOG BOSTON SCIENTIFIC CORPORATION M00545261 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK