BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATOME? XL

    MDR report key: 4092929 · Received September 16, 2014

    Report

    Report Number
    3005099803-2014-03151
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 21, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K930022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #¿S 3005099803-2014-03150 AND 3005099803-2014-03151. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN ATTEMPTING TO PERFORM A SPHINCTEROTOMY, THE DEVICE FAILED TO CUT AND IT WAS NOTED THAT THE DEVICE DID NOT BEND PROPERLY. ANOTHER ULTRATOME XL WAS USED, HOWEVER, THE SAME ISSUE OCCURRED. REPORTEDLY, THE DEVICE¿S ELECTRICAL FUNCTIONALITY WAS TESTED WITH TWO DIFFERENT CAUTERY MACHINES DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THE SAME NON BSC ACTIVE CORD. 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
    573066 ULTRATOME? XL SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00535920 16985301

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR