BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPHINCTEROTOME

    MDR report key: 1792089 · Received August 10, 2010

    Report

    Report Number
    3005099803-2010-03331
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    June 29, 2010
    Report Date
    July 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FDI
    PMA / PMN Number
    K930022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION REVEALED THAT THE WORKING LENGTH WAS TWISTED, THE EXPOSED CUT WIRE WAS DISCOLORED AND APPEARED TO HAVE MELTED/SPLIT THE EXTRUSION AT THE DISTAL PIERCE HOLE. THE MELTED EXTRUSION, CREATED A TEAR MEASURING APPROXIMATELY 6MM PROXIMALLY FROM THE DISTAL PIERCE HOLE, THUS ELONGATING THE DISTAL PIERCE HOLE. THIS TEAR CAUSED THE CUTTING WIRE ANCHOR TO SLIDE PROXIMALLY FROM THE DISTAL PIERCE HOLE AND SHORTENED THE EXPOSED CUTTING WIRE LENGTH, WHICH NOW DOES NOT MEET SPECIFICATION. A FUNCTIONAL EVALUATION FOUND THAT THE DEVICE DID NOT MEET THE BOWING SPECIFICATION AS A RESULT OF THE MELTED/SPLIT EXTRUSION. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE DEVICE WOULD NOT BOW; THE MELTED/SPLIT EXTRUSION HINDERED THE DEVICE'S BOWING FUNCTIONALITY. DURING MANUFACTURING, TOME DEVICES ARE 100% INSPECTED SO THE MELTED/SPLIT EXTRUSION IS LIKELY DUE TO PROCEDURAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4) (WON'T BOW). THE REPORTED EVENT OF WIRE WON'T BOW. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS AND PRELIMINARY FINDINGS INDICATE THE EXTRUSION IS MELTED/SPLIT . UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, AND / OR IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, 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 PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE TOME WOULD NOT BOW. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRATOME XL SPHINCTEROTOME . 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 FINE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH INDICATE THE EXTRUSION IS MELTED/SPLIT.

    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 PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE TOME WOULD NOT BOW. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRATOME XL SPHINCTEROTOME . 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 FINE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH INDICATE THE EXTRUSION IS MELTED/SPLIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPHINCTEROTOME SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - SPENCER M00530820

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR