BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC BILIARY CATHETER

    MDR report key: 2020530 · Received March 16, 2011

    Report

    Report Number
    3005099803-2011-00917
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQR
    PMA / PMN Number
    K946358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 SUBMITTED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH WAS TWISTED AND THE EXPOSED CUTTING WIRE WAS BENT AND BROKEN. THE PROXIMAL END OF THE BROKEN CUTTING WIRE HAD RETRACTED INSIDE THE LUMEN OF THE EXTRUSION THROUGH THE PROXIMAL PIERCE HOLE. THE CUTTING WIRE WAS DISCOLORED FROM USE AND BROKEN ENDS OF THE CUTTING WIRE APPEARED BURNT/BLACKENED. THE OUTER DIAMETER (OD) OF THE EXPOSED CUTTING WIRE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE CUTTING WIRE BROKE. DURING MANUFACTURING, THE SPHINCTEROTOME DEVICES ARE 100% INSPECTED AND THE BROKEN CUTTING WIRE IS LIKELY DUE TO PROCEDURAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A SEARCH OF THE COMPLAINT DATABASE FOUND THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE TO RELIEVE JAUNDICE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, AFTER PERFORMING THE SPHINCTEROTOMY, IT WAS NOTED THAT THE CUTTING WIRE WAS BROKEN WHEN VIEWING THE DEVICE ENDOSCOPICALLY. NO PORTION OF THE CUTTING WIRE DETACHED FROM THE DEVICE INSIDE OF THE PATIENT. THE SPHINCTEROTOMY PROCEDURE WAS COMPLETED USING THIS STONETOME 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE TO RELIEVE JAUNDICE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, AFTER PERFORMING THE SPHINCTEROTOMY, IT WAS NOTED THAT THE CUTTING WIRE WAS BROKEN WHEN VIEWING THE DEVICE ENDOSCOPICALLY. NO PORTION OF THE CUTTING WIRE DETACHED FROM THE DEVICE INSIDE OF THE PATIENT. THE SPHINCTEROTOMY PROCEDURE WAS COMPLETED USING THIS STONETOME 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPIC BILIARY CATHETER DISLODGER, STONE, BILIARY LQR BOSTON SCIENTIFIC - SPENCER M00535110 13946922

    Patients

    Seq Age Sex Outcome Treatment
    1