BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATOME¿ XL

    MDR report key: 2871648 · Received December 13, 2012

    Report

    Report Number
    3005099803-2012-05815
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 23, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FDI
    PMA / PMN Number
    K930022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT: CUT WIRE BROKE. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH OF THE DEVICE WAS TWISTED AND THE EXPOSED CUT WIRE WAS BROKEN AND BLACKENED. THE PROXIMAL SECTION OF THE CUT WIRE WAS BENT PERPENDICULAR TO THE EXTRUSION. THE DISTAL SECTION OF THE CUT WIRE WAS BROKEN OFF AT THE ANCHOR AND THE MEDIAL PORTION OF THE WIRE WAS NOT RETURNED. EXAMINATION OF THE DISTAL END OF THE WIRE FOUND THAT IT HAD BEEN SECURELY ATTACHED TO THE ANCHOR PRIOR TO BREAKING. BOTH PIERCE HOLES WERE MELTED; THE PROXIMAL PIERCE HOLE WAS TORN PROXIMALLY 3 MM AND THE DISTAL PIERCE HOLE WAS CHARRED AND MELTED 2 MM. THE OUTER DIAMETER OF THE BROKEN CUT WIRE WAS MEASURED AND FOUND TO MEET SPECIFICATION. REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT WAS OPERATIONAL CONTEXT, LIKELY DUE TO THE PROCEDURAL FACTORS/GENERATOR SETTINGS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED DURING A PAPILLOTOMY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE PROCEDURE WAS TREATMENT FOR A STONE WITHIN THE COMMON BILE DUCT. DURING THE PROCEDURE, THE CUT WIRE OF THE SPHINCTEROTOME BROKE ON ONE END WITH THE OTHER END STILL ATTACHED. NO PART OF THE DEVICE FELL OFF INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRATOME XL. 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 STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED DURING A PAPILLOTOMY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE PROCEDURE WAS TREATMENT FOR A STONE WITHIN THE COMMON BILE DUCT. DURING THE PROCEDURE, THE CUT WIRE OF THE SPHINCTEROTOME BROKE ON ONE END WITH THE OTHER END STILL ATTACHED. NO PART OF THE DEVICE FELL OFF INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRATOME XL. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRATOME¿ XL SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - SPENCER M00535900 14845633

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR