BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME RX SPHINCTEROTOME

    MDR report key: 2011556 · Received March 9, 2011

    Report

    Report Number
    3005099803-2011-00755
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 USAGE AND THE BROKEN ENDS 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 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. THE DEVICE HISTORY RECORD REVIEW FOUND THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE EXACT PATIENT AGE IS UNKNOWN. HOWEVER, THE PATIENT IS (B)(6). 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 REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUT WIRE BROKE. NO PORTION OF THE CUT WIRE DETACHED FROM THE DEVICE INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME RX 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 AN AUTOTOME RX SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC SPHINCTEROTOMY(EST) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUT WIRE BROKE. NO PORTION OF THE CUT WIRE DETACHED FROM THE DEVICE INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME RX 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 AUTOTOME RX SPHINCTEROTOME UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00545170 13884671

    Patients

    Seq Age Sex Outcome Treatment
    1