BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPHINCTEROTOME

    MDR report key: 2032219 · Received March 29, 2011

    Report

    Report Number
    3005099803-2011-01091
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FDI
    PMA / PMN Number
    K930022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH WAS TWISTED AND BENT, AND THE EXPOSED CUTTING WIRE WAS BROKEN AND BENT. THE PROXIMAL END OF THE BROKEN CUTTING WIRE HAD RETRACTED INSIDE THE LUMEN OF THE EXTRUSION THROUGH THE PROXIMAL PIERCE HOLE. THE BROKEN ENDS OF THE CUTTING WIRE APPEARED BURNT/BLACKENED INDICATING ELECTRICAL ACTIVATION OF THE DEVICE. THE OUTER DIAMETER (OD) OF THE CUTTING WIRE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. IN ADDITION, IT WAS FOUND THAT THE WIDE BLUE PAINT MARKER BAND AT THE DISTAL TIP WAS CHIPPED/PEELED. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE CUTTING WIRE BROKE. DURING MANUFACTURING, THE SPHINCTEROTOME DEVICE ARE 100% INSPECTED AND THE BROKEN CUTTING WIRE IS LIKELY DUE TO PREPARATORY/PROCEDURAL FACTORS. AS THE COMPLAINANT INDICATED THAT THE PROBLEM WAS NOTICED DURING PREPARATION, THE MOST PROBABLE ROOT CAUSE IS HANDLING DAMAGE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL SPHINCTEROTOME WAS TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE CUTTING WIRE BROKE WHEN THE DEVICE WAS BOWED TO TEST FOR FUNCTIONALITY. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL SPHINCTEROTOME WAS TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE CUTTING WIRE BROKE WHEN THE DEVICE WAS BOWED TO TEST FOR FUNCTIONALITY. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPHINCTEROTOME SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - SPENCER M00535920 13981175

    Patients

    Seq Age Sex Outcome Treatment
    1