BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INQUIRY STEERABLE 6F CATHETER, 1110-6-25-M

    MDR report key: 2043296 · Received February 25, 2011

    Report

    Report Number
    2030404-2011-00056
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 28, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    DRF
    PMA / PMN Number
    K082061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED CATHETER REVEALED ELECTRODE BAND #4 HAD SHIFTED FROM ITS ORIGINAL POSITION TOWARD THE POSITION OF ELECTRODE BAND #3. THE CATHETER DIAMETER WAS VERIFIED USING THE (B)(4) CATHETER SCALE TO BE A 6F CATHETER. FUNCTIONAL TESTING VERIFIED THE CATHETER CREATED A CURVE THAT MATCHED THE TEMPLATE REQUIREMENTS AND THAT STEERING FORCE TO CREATE A CURVE WAS WITHIN SPECIFICATION. FURTHER INVESTIGATION REVEALED ELECTRODE BAND #4 DISCONNECTED FROM THE CONDUCTOR WIRE AND SHIFTED TOWARD THE POSITION OF ELECTRODE BAND #3. THE INVESTIGATION RESULTS ARE CONSISTENT WITH THE REPORTED EVENT OF FORCE BEING REQUIRED TO REMOVE THE CATHETER. WHY THE CATHETER BECAME "ENTRAPPED" IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER BECAME "ENTRAPPED" IN THE PT'S HEART. THE PHYSICIAN "PULLED HARD" TO REMOVE THE CATHETER AND IT COLLAPSED ON ITSELF AND THE POLES OF THE CATHETER SLID TOGETHER. THERE WERE NO CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INQUIRY STEERABLE 6F CATHETER, 1110-6-25-M NONE DRF ST. JUDE MEDICAL, IRVINE 81102 K30340

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR