BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME RX SPHINCTEROTOME

    MDR report key: 2142399 · Received June 28, 2011

    Report

    Report Number
    3005099803-2011-02254
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 FILE.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH WAS TWISTED, THE EXPOSED CUT WIRE WAS BROKEN AND THE BROKEN ENDS OF THE CUTTING WIRE APPEARED BLACKENED. 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. FURTHER ANALYSIS OF THE CUTTING WIRE FOUND IT BROKE AT APPROXIMATELY 26 MM FROM THE DISTAL PIERCE HOLE. THE OUTER DIAMETER (OD) OF THE EXPOSED CUT WIRE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. ADDITIONALLY, THE CLOSED EXTRUSION AT THE DISTAL TIP WAS RIPPED. THE RIP EXISTED FROM THE POINT WHERE THE GUIDE WIRE CHANNEL ENDS, TO THE TIP, TEARING OPEN THE CLOSED EXTRUSION THROUGH THE DISTAL TIP AND SPLITTING THE TIP. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE CUT WIRE BROKE. 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 AUTOTOME RX SPHINCTEROTOME WAS USED IN THE BILIARY DUCT FOR AN ENDOSCOPIC SPHINCTERECTOMY (EST) PROCEDURE OF THE PAPILLA. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUT WIRE BROKE; NO PART OF THE CUT WIRE FELL INSIDE 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 OK.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A AUTOTOME RX SPHINCTEROTOME WAS USED IN THE BILIARY DUCT FOR AN ENDOSCOPIC SPHINCTERECTOMY (EST) PROCEDURE OF THE PAPILLA. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUT WIRE BROKE; NO PART OF THE CUT WIRE FELL INSIDE 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 OK.

    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 M00545180 14152156

    Patients

    Seq Age Sex Outcome Treatment
    1