BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATOME¿

    MDR report key: 2222210 · Received August 24, 2011

    Report

    Report Number
    3005099803-2011-02916
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FDI
    PMA / PMN Number
    K930022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT: (B)(6). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON 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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE WORKING LENGTH TO BE KINKED AT APPROXIMATELY 73CM FROM THE DISTAL END OF THE HEAT SHRINK. A FUNCTIONAL EVALUATION WAS PERFORMED BY INSERTING A 0.035" JAGWIRE GUIDEWIRE THROUGH THE DEVICE TIP AND TO THE KINKED AREA. THE GUIDEWIRE COULD NOT BE PASSED BEYOND THE KINKED SECTION. NO OTHER ISSUES WERE NOTED TO THE DEVICE. FOLLOWING A DETAILED DEVICE ANALYSIS, IT WAS NOTED THAT THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH. AS IT IS UNKNOWN WHEN AND HOW THE KINK OCCURRED TO THE DEVICE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A 0.035" JAGWIRE GUIDEWIRE WAS ADVANCED DOWN THE ENDOSCOPE AND POSITIONED WITHIN THE PATIENT. HOWEVER, DIFFICULTY WAS ENCOUNTERED WHEN BACKLOADING THE SPHINCTEROTOME OVER THE GUIDEWIRE. THE SPHINCTEROTOME WAS REMOVED FROM THE GUIDEWIRE. UPON REMOVAL, THE USER STATED THAT THE SPHINCTEROTOME APPEARED TO BE KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRATOME SPHINCTEROTOME ALONG WITH THE SAME GUIDEWIRE. THE USER ALLEGED NO COMPLAINT AGAINST THE GUIDEWIRE USED IN THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A 0.035" JAGWIRE GUIDEWIRE WAS ADVANCED DOWN THE ENDOSCOPE AND POSITIONED WITHIN THE PATIENT. HOWEVER, DIFFICULTY WAS ENCOUNTERED WHEN BACKLOADING THE SPHINCTEROTOME OVER THE GUIDEWIRE. THE SPHINCTEROTOME WAS REMOVED FROM THE GUIDEWIRE. UPON REMOVAL, THE USER STATED THAT THE SPHINCTEROTOME APPEARED TO BE KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRATOME SPHINCTEROTOME ALONG WITH THE SAME GUIDEWIRE. THE USER ALLEGED NO COMPLAINT AGAINST THE GUIDEWIRE USED IN THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRATOME¿ SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - SPENCER M00530800 14045529

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR