BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1161491 · Received September 11, 2008

    Report

    Report Number
    3005099803-2008-04585
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT A HYDRATOME RX SPHINCTEROTOME DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON FOUR DAYS EARLIER. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE TOME WAS BACKLOADED OVER THE GUIDEWIRE, THE TIP WAS DAMAGED. THE GUIDEWIRE CAME OUT OF THE SIDE OF THE SPHINCTEROTOME; THE TIP ORIENTATION WAS INACCURATE. ANOTHER HYDRATOME RX SPHINCTEROTOME DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583040 11885995

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR