BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME RX SPHINCTEROTOME

    MDR report key: 1454739 · Received May 4, 2009

    Report

    Report Number
    3005099803-2009-02225
    Event Type
    Malfunction
    Date Received
    May 4, 2009
    Date of Event
    January 23, 2009
    Report Date
    April 7, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (THE GUIDEWIRE COULD NOT BE EXPOSED). A VISUAL EXAMINATION FOUND THAT THE GUIDEWIRE LUMEN WAS NOT SLIT TO MAKE THE OPEN GUIDEWIRE CHANNEL AND THE WORKING LENGTH WAS BENT NEAR THE DISTAL END. THIS PREVENTED THE GUIDEWIRE FROM BEING EXPOSED AND SEPARATED FROM THE TOME. THE WORKING LENGTH WITH THE ENCLOSED CUTTING WIRE WAS FOUND TO BE BENT APPROX 50, 65 AND 77 MM FROM THE DISTAL TIP. IT IS LIKELY, THIS OCCURRED DURING THE CUSTOMER ATTEMPT TO SEPARATE THE GUIDEWIRE FROM THE GUIDEWIRE LUMEN. A FUNCTIONAL TEST OF THE GUIDEWIRE WAS PERFORMED BY INSERTING A 0.035" GUIDEWIRE THROUGH THE INTRODUCER AND ADVANCING IT THROUGH THE CHANNEL. IT WAS FOUND THAT THE GUIDEWIRE EXITS OUT THROUGH THE DISTAL TIP AS INTENDED. THOUGH THE GUIDEWIRE LUMEN ACCEPTED THE 0.035" GUIDEWIRE, THE GUIDEWIRE COULD NOT BE SEPARATED AND EXPOSED (RAPID EXCHANGE) SINCE THE GUIDEWIRE LUMEN WAS NOT SLIT TO FORM THE OPEN CHANNEL. THE ROOT CAUSE OF THE REPORTED COMPLAINT IS MANUFACTURING. (B) (4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 23, 2009, THAT DURING THE PROCEDURE WHEN THE CATHETER WAS ADVANCING ALONG WITH THE GUIDEWIRE, THE PHYSICIAN BENT THE CATHETER A LITTLE TO CHECK THE GUIDEWIRE. HOWEVER, THE GUIDEWIRE WAS NOT EXPOSED OUT OF THE LUMEN NEAR THE BROWN MARKER. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION WAS REPORTED TO BE GOOD. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; CUTWIRE IS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOTOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORP M00545150 11795809

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK