BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONETOME¿

    MDR report key: 2415902 · Received January 13, 2012

    Report

    Report Number
    3005099803-2012-00017
    Event Type
    Malfunction
    Date Received
    January 13, 2012
    Date of Event
    December 20, 2011
    Report Date
    December 21, 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

    BLOCK A2: PATIENTS AGE IS UNKNOWN, HOWEVER, THE PATIENT IS OVER 18 YEARS.(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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH WAS TWISTED, THE EXPOSED CUT WIRE WAS BROKEN NEAR THE PROXIMAL PIERCE HOLE AND THE BROKEN END APPEARED DISCOLORED/BLACKENED. THE DISTAL END OF CUT WIRE REMAINED INTACT TO THE ANCHOR NOTCH ASSEMBLY AND REMAINED INSIDE THE DISTAL PIERCE HOLE. THE OUTER DIAMETER (OD) OF THE EXPOSED CUT WIRE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. DURING MANUFACTURING, TOME DEVICES ARE 100% INSPECTED SO THE BROKEN CUT WIRE IS LIKELY DUE TO PROCEDURAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR 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 A STONETOME SPHINCTEROTOME WAS USED DURING ENDOSCOPIC SPHINCTERECTOMY (EST) PROCEDURE. ACCORDING TO THE COMPLAINANT, WHEN MAKING AN INCISION BELOW THE HEAD OF THE TRANSVERSE FOLD OF THE PAPILLA, THE CUT WIRE BROKE; NO PART DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. RESISTANCE WAS ENCOUNTERED WHEN REMOVING THE DEVICE FROM THE ENDOSCOPE. 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 ENDOSCOPIC SPHINCTERECTOMY (EST) PROCEDURE.ACCORDING TO THE COMPLAINANT, WHEN MAKING AN INCISION BELOW THE HEAD OF THE TRANSVERSE FOLD OF THE PAPILLA, THE CUT WIRE BROKE; NO PART DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. RESISTANCE WAS ENCOUNTERED WHEN REMOVING THE DEVICE FROM THE ENDOSCOPE.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 STONETOME¿ DISLODGER, STONE, BILIARY LQR BOSTON SCIENTIFIC - SPENCER M00535170 14399822

    Patients

    Seq Age Sex Outcome Treatment
    1