BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATOME? XL

    MDR report key: 3934643 · Received July 15, 2014

    Report

    Report Number
    3005099803-2014-02443
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K930022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    RESULTS: NO FAILURE DETECTED: THE ALLEGED FAILURE "THE ULTRATOME FAILED TO CUT - IT HEATED BUT WOULD NOT CUT. ¿ COULD NOT BE DUPLICATED, HOWEVER, THE WORKING LENGTH WAS FOUND TO BE TWISTED. INVESTIGATION RESULTS: VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THE WORKING LENGTH TWISTED. FUNCTIONALLY, A RESISTANCE TEST WAS PERFORMED, AND FOUND TO BE WITHIN SPECIFICATION. THE DEVICE SHOWED NO EVIDENCE OF THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. THE COMPLAINT WAS NOT CONFIRMED. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO DEVIATION WAS FOUND. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME¿ XL WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE THE DEVICE HEATED BUT FAILED TO CUT. ADDITIONALLY, THE DEVICE WAS INSPECTED AND NO DAMAGE WERE NOTICED PRIOR TO USE. THE PROCEDURE WAS COMPLETED USING ANOTHER ULTRATOME¿ XL. 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE THE DEVICE HEATED BUT FAILED TO CUT. ADDITIONALLY, THE DEVICE WAS INSPECTED AND NO DAMAGE WERE NOTICED PRIOR TO USE. THE PROCEDURE WAS COMPLETED USING ANOTHER ULTRATOME XL. 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414217 ULTRATOME? XL SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00535900 16736887

    Patients

    Seq Age Sex Outcome Treatment
    1