BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE STEP BUTTON INITIAL PLACEMENT KIT

    MDR report key: 1031367 · Received April 18, 2008

    Report

    Report Number
    3005099803-2008-00364
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    February 19, 2008
    Report Date
    March 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KGC
    PMA / PMN Number
    K910584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED; THE SNARE LOOP WIRE WAS BENT; THE SNARE LOOP WIRE AND THE CRIMPED CANNULA HAD DETACHED FROM THE CONNECTING WIRE; THE DISTAL END OF THE CONNECTING WIRE WAS COINED, CONFIRMING IT HAD BEEN CRIMPED AS INTENDED DURING THE MANUFACTURING PROCESS. IT WAS OBSERVED, HOWEVER, THAT THE CANNULA CRIMP-TO-CRIMP SPACING WAS TOO NARROW, RESULTING IN AN INADEQUATE JOINT STRENGTH AND, ULTIMATELY LEADING TO THE REPORTED SNARE LOOP WIRE DETACHMENT. A SEARCH OF THE COMPLAINT DATABASE REVEALED NO ADDITIONAL COMPLAINTS FOR THE LOT. THE FEBRUARY 2008 15 - MONTH ONE STEP BUTTON - ENTERAL FEEDING PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    A ONE STEP BUTTON INITIAL PLACEMENT KIT WAS USED DURING A PEG INITIAL PLACEMENT PROCEDURE (PATIENT AGE, GENDER, AND WEIGHT UNKNOWN) IN 2008. ACCORDING TO THE COMPLAINANT, WHEN THE RETRIEVAL DEVICE WAS REMOVED FROM THE KIT, THE LOOP FROM THE SHEATH WAS FOUND TO HAVE DETACHED FROM THE CANNULA. THE PHYSICIAN RETRIEVED THE SNARE LOOP AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE [PRODUCT AND MANUFACTURER UNKNOWN]. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE STEP BUTTON INITIAL PLACEMENT KIT KGC BOSTON SCIENTIFIC CORPORATION M00568520 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK