BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1191931 · Received October 1, 2008

    Report

    Report Number
    3005099803-2008-04976
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Report Date
    September 2, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A DEVICE EVAL IS NOT AVAILABLE; THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP IN 2008, THAT A HYDRATOME RX SPHINCTEROTOME DEVICE WAS USED FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINT, WHEN THE SPHINCTEROTOME "ENTERED OUT OF THE SCOPE THE ORIENTATION WAS INCORRECT. THE PRODUCT WAS TAKEN OUT OF THE SCOPE AND THEY TRIED TO TWIST THE TIP OF THE SPHINCTEROTOME BACK TO THE ORIGINAL SHAPE BUT THE SPHINCTEROTOME WOULD NOT GO BACK TO THE ORIGINAL ORIENTATION." THE PROCEDURE WAS COMPLETED WITH A COOK DEVICE (PRODUCT UNK). 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 "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583020 11558532

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK