BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPHINCTEROTOME

    MDR report key: 1881165 · Received October 25, 2010

    Report

    Report Number
    3005099803-2010-04449
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    August 31, 2010
    Report Date
    October 5, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FDI
    PMA / PMN Number
    K930022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 7 MM PROXIMALLY FROM 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 CUT WIRE WOULD NOT BOW, HOWEVER, THIS WAS ATTRIBUTED TO MELTED/SPLIT EXTRUSION. DURING MANUFACTURING, TOME DEVICES ARE 100% INSPECTED, THE MELTED/SPLIT EXTRUSION IS LIKELY DUE TO PROCEDURAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND REVEALED NO RELATED ISSUES TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON 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.

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS ONE OF THREE COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2010-04447, MFR. REPORT # 3005099803-2010-04448 AND MFR. REPORT # 3005099803-2010-04449). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE ULTRATOME SPHINCTEROTOMES WERE USED DURING A STONE EXTRACTION PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN CANNULATED THE PAPILLA WITH A CATHETER AND PLACED A JAGWIRE INTO THE LEFT HEPATIC DUCT. HE THEN OBTAINED AN ULTRATOME AND ADVANCED IT HALFWAY INTO THE PAPILLA (UP TO THE GREEN MARKER). THE ASSISTANT BOWED THE TOME HALF WAY AND THE PHYSICIAN MADE A LITTLE CUT TO THE PAPILLA. THE PHYSICIAN WANTED TO MAKE A BIGGER CUT BUT THE TOME WOULD NOT BOW FULLY, SO IT WAS NOT POSSIBLE. THE FIRST ULTRATOME DEVICE WAS REMOVED, A SECOND ULTRATOME SPHINCTEROTOME WAS OBTAINED AND THE SAME PROBLEM OCCURRED. THE SECOND ULTRATOME SPHINCTEROTOME DEVICE WAS REMOVED, A THIRD ULTRATOME SPHINCTEROTOME WAS OBTAINED AND THE SAME PROBLEM OCCURRED. THE THIRD ULTRATOME SPHINCTEROTOME WAS REMOVED, A FOURTH ULTRATOME SPHINCTEROTOME WAS OBTAINED AND USED TO COMPLETE THE PROCEDURE. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON PRELIMINARY INVESTIGATION RESULTS; MELTED EXTRUSION.

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS ONE OF THREE COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2010-04447, MFR. REPORT # 3005099803-2010-04448 AND MFR. REPORT # 3005099803-2010-04449). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE ULTRATOME SPHINCTEROTOMES WERE USED DURING A STONE EXTRACTION PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN CANNULATED THE PAPILLA WITH A CATHETER AND PLACED A JAGWIRE INTO THE LEFT HEPATIC DUCT. HE THEN OBTAINED AN ULTRATOME AND ADVANCED IT HALFWAY INTO THE PAPILLA (UP TO THE GREEN MARKER). THE ASSISTANT BOWED THE TOME HALF WAY AND THE PHYSICIAN MADE A LITTLE CUT TO THE PAPILLA. THE PHYSICIAN WANTED TO MAKE A BIGGER CUT BUT THE TOME WOULD NOT BOW FULLY, SO IT WAS NOT POSSIBLE. THE FIRST ULTRATOME DEVICE WAS REMOVED, A SECOND ULTRATOME SPHINCTEROTOME WAS OBTAINED AND THE SAME PROBLEM OCCURRED. THE SECOND ULTRATOME SPHINCTEROTOME DEVICE WAS REMOVED, A THIRD ULTRATOME SPHINCTEROTOME WAS OBTAINED AND THE SAME PROBLEM OCCURRED. THE THIRD ULTRATOME SPHINCTEROTOME WAS REMOVED, A FOURTH ULTRATOME SPHINCTEROTOME WAS OBTAINED AND USED TO COMPLETE THE PROCEDURE. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON PRELIMINARY INVESTIGATION RESULTS; MELTED EXTRUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPHINCTEROTOME SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - SPENCER M00530800 0013356014

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR