BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPHINCTEROTOME

    MDR report key: 1860485 · Received October 7, 2010

    Report

    Report Number
    3005099803-2010-04183
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 20, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FDI
    PMA / PMN Number
    K930022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS UNKNOWN. (B)(4) - THE REPORTED EVENT OF CUT WIRE SEPARATED. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ULTRATOME XL SPHINCTEROTOME WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY CANNULATED THE PATIENT'S COMMON BILE DUCT AND THEN PUSHED THE DEVICE INTO THE COMMON BILE DUCT. A SPHINCTEROTOMY WAS PERFORMED AND THE DEVICE WAS PULLED OUT OF THE DUCT, AT THIS POINT IT WAS NOTED THE CUT WIRE SEPARATED; NO PART FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED AT THIS POINT, THEREFORE, ANOTHER DEVICE WAS NOT NEEDED. 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 SPHINCTEROTOME SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - SPENCER M00535900 13580370

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR