BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPHINCTEROTOME

    MDR report key: 2083643 · Received May 10, 2011

    Report

    Report Number
    3005099803-2011-01712
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    March 24, 2011
    Report Date
    May 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FDI
    PMA / PMN Number
    K930022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) RELATES TO (B)(4) FOR THE EVALUATION FINDINGS OF CATHETER SPLIT AT THE EXTRUSION. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH WAS TWISTED AND THE EXPOSED CUTTING WIRE APPEARED TO HAVE MELTED/SPLIT THE EXTRUSION AT THE DISTAL PIERCE HOLE. THE DISTAL PIERCE HOLE WAS MEASURED AND DID NOT MEET THE SPECIFICATION FOR THE MAXIMUM ACCEPTABLE PIERCE HOLE ELONGATION. THE SPLIT EXTRUSION CAUSED THE CUTTING WIRE ANCHOR TO SLIDE PROXIMALLY AND THEREBY SHORTENED THE EXPOSED CUTTING WIRE LENGTH. A FUNCTIONAL EVALUATION FOUND THAT THE DEVICE DID NOT MEET THE MINIMUM BOWING SPECIFICATION DUE TO THE SPLIT EXTRUSION AND THE RESULTING SHORTENED EXPOSED CUTTING WIRE LENGTH. IN ADDITION, THE CUTTING WIRE APPEARED DISCOLORED FROM USE. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE DEVICE FAILED TO BOW. DURING MANUFACTURING, THE SPHINCTEROTOME DEVICES ARE 100% INSPECTED AND THE SPLIT EXTRUSION IS LIKELY DUE TO PROCEDURAL/ANATOMICAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL PRODUCT SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH.

    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 DEVICE FAILED TO BOW WHEN THE HANDLE WAS ACTUATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRATOME XL SPHINCTEROTOME. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE." BASED ON THE INVESTIGATION RESULTS, WHICH FOUND THE EXTRUSION TO BE SPLIT AT THE DISTAL PIERCE HOLE, THIS EVENT IS NOW CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPHINCTEROTOME SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - SPENCER M00535900 13977889

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR