BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME RX SPHINCTEROTOME

    MDR report key: 2122408 · Received June 13, 2011

    Report

    Report Number
    3005099803-2011-02018
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE (B)(4) RELATES TO (B)(4) FOR THE REPORTED EVENT OF CUTWIRE DETACHED. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A AUTOTOME RX SPHINCTEROTOME WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT FOR A POST CHOLECYSTECTOMY LEAK FROM WITHIN THE HEPATIC DUCT. ACCORDING TO THE COMPLAINANT, WHILE COMPLETING THE SPHINCTEROTOMY OF THE COMMON BILE DUCT SPHINCTER THE DEVICE SPARKED TWICE. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT IT WAS OBSERVED THAT THE CUT WIRE MELTED OFF THE TOME LEAVING ONLY A SMALL PIECE OF THE WIRE HANGING FROM THE PROXIMAL END OF THE TOME. NO PART OF THE CUT WIRE WAS FOUND INSIDE THE PATIENT. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOTOME RX SPHINCTEROTOME UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00545170 14244851

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR