BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME RX SPHINCTEROTOME

    MDR report key: 1171468 · Received September 17, 2008

    Report

    Report Number
    3005099803-2008-04649
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 18, 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
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE WILL BE RETURNED FOR EVALUATION, IT HAS NOT BEEN RECEIVED. THE DEVICE EVALUATION IS NOT AVAILABLE; THEREFORE, THE CAUSE OF THE REPORTED WIRE BREAKAGE IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO EVENTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #3005099803-2008-04650 FOR A DESCRIPTION OF THE RELATED EVENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT AN AUTOTOME RX SPHINCTEROTOME DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ONE DAY PRIOR. ACCORDING TO THE COMPLAINANT, WHILE PERFORMING A SPHINCTEROTOMY OF THE PAPILLA, THE WIRE OF THE SPHINCTEROTOME "SNAPPED. NOTHING FELL INTO THE PATIENT." THE CASE WAS COMPLETED WITH ANOTHER AUTOTOME RX SPHINCTEROTOME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'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 AUTOTOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00545170 11892224

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK