BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME RX SPHINCTEROTOME

    MDR report key: 1894416 · Received November 9, 2010

    Report

    Report Number
    3005099803-2010-04645
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    July 9, 2010
    Report Date
    October 20, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), (WON'T BOW IN PLANE). (B)(4) RELATES TO (B)(4) FOR THE INVESTIGATION RESULTS OF BENT WIRE. THESE CODES WERE SELECTED BY THE MANUFACTURER BASED ON THE CONDITION OF THE DEVICE FOLLOWING THE DEVICE INVESTIGATION. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH WAS TWISTED AND CUT WIRE WAS BENT. THE INITIAL TIP ORIENTATION DID NOT MEET THE ORIENTATION SPECIFICATION. THE ORIENTATION OF THE DISTAL TIP COULD BE ADJUSTED LEFT OR RIGHT BY ROTATING THE HANDLE BUT COULD NOT BE SET WITHIN ORIENTATION SPECIFICATION DUE TO TWISTED TIP/ BENT WIRE. FUNCTIONALLY, WHEN BOWING IT WAS FOUND THE TIP DID NOT BOW IN PLANE AS A RESULT OF THE BENT CUT WIRE. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE ORIENTATION WAS INCORRECT. DURING MANUFACTURING, TOME DEVICES ARE 100% INSPECTED SO THE BENT 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 DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE EXITED THE SCOPE AND THE ORIENTATION WAS INCORRECT. THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME RX SPHINCTEROTOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; BENT WIRE AND NOT BOWING IN PLANE.

    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 13403688

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR