BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATOME¿ XL

    MDR report key: 2181720 · Received July 27, 2011

    Report

    Report Number
    3005099803-2011-02558
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FDI
    PMA / PMN Number
    K930022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE EXTRUSION WAS KINKED ON BOTH SIDES OF THE BROWN BAND. IN ADDITION, THE DEVICE WAS KINKED IN MULTIPLE LOCATIONS ALONG THE WORKING LENGTH. THE LENGTH OF THE EXPOSED CUTTING WIRE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. A FUNCTIONAL EVALUATION FOUND THAT THE DEVICE MET THE MINIMUM BOWING SPECIFICATION. DURING MANUFACTURING, THE SPHINCTEROTOME DEVICES ARE 100% INSPECTED AND THE KINKED EXTRUSION AND WORKING LENGTH ARE LIKELY DUE TO CUSTOMER USAGE/PROCEDURAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT. 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.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SPHINCTEROTOME WAS INSERTED INTO THE PAPILLA. HOWEVER, THE DEVICE WAS DIFFICULT TO BOW. UPON INSPECTION, IT WAS DISCOVERED THAT THE CATHETER OF THE SPHINCTEROTOME WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRATOME XL SPHINCTEROTOME. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SPHINCTEROTOME WAS INSERTED INTO THE PAPILLA. HOWEVER, THE DEVICE WAS DIFFICULT TO BOW. UPON INSPECTION, IT WAS DISCOVERED THAT THE CATHETER OF THE SPHINCTEROTOME WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRATOME XL SPHINCTEROTOME. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRATOME¿ XL SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - SPENCER M00535900 14112948

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR