BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONETOME¿

    MDR report key: 2429578 · Received January 26, 2012

    Report

    Report Number
    3005099803-2012-00034
    Event Type
    Malfunction
    Date Received
    January 26, 2012
    Date of Event
    November 18, 2011
    Report Date
    January 3, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQR
    PMA / PMN Number
    K946358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION FINDINGS OF CUTTING WIRE BENT. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH WAS TWISTED. THE CUTTING WIRE WAS INTACT AT THE DISTAL END OF THE DEVICE; THE CUTTING WIRE APPEARED BENT INSIDE OF THE EXTRUSION CLOSE TO THE PROXIMAL END. DURING A FUNCTIONAL EVALUATION, THE DEVICE FAILED TO BOW PAST 90 DEGREES AS THE WORKING LENGTH TENSED/COILED WHEN THE HANDLE WAS ACTUATED. THE LENGTH AND THE OUTER DIAMETER (OD) OF THE CUTTING WIRE WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATION. A SECOND FUNCTIONAL EVALUATION FOUND THAT THE CONTINUITY BETWEEN THE 2-IN-1 CONNECTOR AND THE EXPOSED CUTTING WIRE WAS ABLE TO CONDUCT CURRENT INDICATING PROPER CONNECTIVITY OF THE DEVICE. THE RESISTANCE ACROSS THE 2-IN-1 CONNECTOR AND THE CUTTING WIRE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. 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. THE INVESTIGATION CONCLUDED THAT THE TWISTED WORKING LENGTH AND BENT CUTTING WIRE WERE LIKELY DUE TO PROCEDURAL / ANATOMICAL FACTORS ENCOUNTERED DURING THE PROCEDURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE FAILED TO BOW COMPLETELY WHEN THE HANDLE WAS FULLY ACTUATED. THE PHYSICIAN WAS ABLE TO CUT THE PAPILLA WITH THE SPHINCTEROTOME PARTIALLY BOWED. NO VISIBLE DAMAGE WAS NOTED TO THE DEVICE. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. 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. BASED ON THE DEVICE ANALYSIS, WHICH INDICATES THAT THE CUTTING WIRE WAS BENT, THIS IS NOW CONSIDERED A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STONETOME¿ DISLODGER, STONE, BILIARY LQR BOSTON SCIENTIFIC - SPENCER M00535150 14606283

    Patients

    Seq Age Sex Outcome Treatment
    1