BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATOME¿ XL

    MDR report key: 2844636 · Received November 26, 2012

    Report

    Report Number
    3005099803-2012-05491
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    September 14, 2012
    Report Date
    November 5, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FDI
    PMA / PMN Number
    K930022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF 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. THE BROKEN ENS OF THE CUT WIRE REMAINED ATTACHED TO THE DEVICE- ONE END OF THE BROKEN CUT WIRE ATTACHED TO THE ANCHOR AT THE DISTAL PIERCE HOLE WHILE THE OTHER END HAD RETRACTED INSIDE THE LUMEN OF THE EXTRUSION THROUGH THE PROXIMAL PIERCE HOLE. THE BROKEN ENDS OF THE CUT WIRE APPEARED BLACKENED. THE OUTER DIAMETER OF THE EXPOSED 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 WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH PAPILLOTOMY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PAPILLOTOMY WAS INITIATED, THE CUT WIRE BROKE. NO PART OF THE DEVICE FELL OFF INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A MEDI-GLOBE 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."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH PAPILLOTOMY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PAPILLOTOMY WAS INITIATED, THE CUT WIRE BROKE. NO PART OF THE DEVICE FELL OFF INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A MEDI-GLOBE 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".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRATOME¿ XL SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - SPENCER M00535900 15192643

    Patients

    Seq Age Sex Outcome Treatment
    1