BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC BILIARY CATHETER

    MDR report key: 1883748 · Received October 27, 2010

    Report

    Report Number
    3005099803-2010-04471
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 7, 2010
    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 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, AND / OR IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION REVEALED THAT THE EXPOSED CUT WIRE WAS BENT AND BROKEN. THE BROKEN SECTION OF THE EXPOSED CUTTING WIRE HAD RETRACTED INSIDE THE LUMEN OF THE EXTRUSION THROUGH THE PROXIMAL PIERCE HOLE AND THE OTHER BROKEN SECTION OF THE EXPOSED CUT WIRE WAS ATTACHED TO THE ANCHOR AT THE DISTAL PIERCE HOLE. DURING ANALYSIS, THE RETRACTED CUTTING WIRE WAS PUSHED OUT OF THE EXTRUSION THROUGH THE PROXIMAL PIERCE HOLE. THE BROKEN CUTTING WIRE APPEARED BURNT/BLACKENED. THE OD OF THE EXPOSED CUT WIRE WAS MEASURED AND MEETS THE OD SPECIFICATION. THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE CUTTING WIRE WAS BROKEN. HOWEVER, DURING MANUFACTURING, THE TOME DEVICES ARE 100% INSPECTED FOR CUT WIRE INTEGRITY. THE BENT AND BROKEN CUT WIRE IS LIKELY DUE TO PROCEDURAL FACTORS/ GENERATOR SETTINGS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMS THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME STONE REMOVAL DEVICE WAS USED IN THE COMMON BILE DUCT DURING A STONE REMOVAL PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE CUTTING WIRE WAS ACTIVATED TO INCISE AND CAUTERIZE THE PAPILLA, A SPARK WAS OBSERVED ON THE CUTTING WIRE AND IT WAS FOUND THAT THE EXPOSED CUTTING WIRE WAS BROKEN. NO WIRE FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONETOME STONE REMOVAL DEVICE. 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 STONE REMOVAL DEVICE WAS USED IN THE COMMON BILE DUCT DURING A STONE REMOVAL PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE CUTTING WIRE WAS ACTIVATED TO INCISE AND CAUTERIZE THE PAPILLA, A SPARK WAS OBSERVED ON THE CUTTING WIRE AND IT WAS FOUND THAT THE EXPOSED CUTTING WIRE WAS BROKEN. NO WIRE FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONETOME STONE REMOVAL DEVICE. 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 M00535150

    Patients

    Seq Age Sex Outcome Treatment
    1