BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME RX SPHINCTEROTOME

    MDR report key: 2142619 · Received June 28, 2011

    Report

    Report Number
    3005099803-2011-02236
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH WAS TWISTED AND BENT, AND THE EXPOSED CUT WIRE WAS DISCOLORED AND APPEARED TO HAVE MELTED/SPLIT THE EXTRUSION AT THE DISTAL PIERCE HOLE. THE MELTED EXTRUSION CREATED A TEAR MEASURING APPROXIMATELY 8MM PROXIMALLY FROM THE DISTAL PIERCE HOLE, WHICH ALLOWED THE CUTTING WIRE WITH THE ATTACHED ANCHOR TO SEPARATE FROM THE DISTAL PIERCE HOLE. THE CUTWIRE, HOWEVER, REMAINED ATTACHED AT THE PROXIMAL PIERCE HOLE. 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 WAS BROKEN. THE EVALUATION FOUND THAT THE CUTWIRE WITH ANCHOR SEPARATED FROM THE DISTAL PIERCE HOLE. DURING MANUFACTURING, TOME DEVICES ARE 100% INSPECTED SO THE CUTWIRE SEPARATION LIKELY OCCURRED 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.

    Additional Manufacturer Narrative · 1

    PATIENTS AGE IS UNKNOWN, HOWEVER, THE PATIENT IS OVER 18 YEARS. 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, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE AUTOTOME'S CUT WIRE BROKE; NOTHING DETACHED IN THE PATIENT. THE AUTOTOME WAS REMOVED AND A DREAMTOME WAS PLACED OVER THE AUTOTOME'S GUIDEWIRE. THE DREAMTOME'S CUT WIRE WAS DAMAGED/WARPED AND WOULD NOT BOW IN PLANE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2011-02235, AND 3005099803-2011-02236 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX SPHINCTEROTOME AND AUTOTOME RX SPHINCTEROTOME WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DREAMTOME'S CUT WIRE BROKE; NOTHING DETACHED IN THE PATIENT. THE DREAMTOME WAS REMOVED AND AN AUTOTOME WAS PLACED OVER THE DREAMTOME'S GUIDEWIRE. THE AUTOTOME'S CUT WIRE WAS DAMAGED/WARPED AND WOULD NOT BOW IN PLANE. 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 FINE.

    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 14240955

    Patients

    Seq Age Sex Outcome Treatment
    1