BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INQUIRY AFOCUSII, 1120-7-4-SM-AF20DL CATHETER

    MDR report key: 2592284 · Received May 25, 2012

    Report

    Report Number
    2030404-2012-00158
    Event Type
    Malfunction
    Date Received
    May 25, 2012
    Date of Event
    May 4, 2012
    Report Date
    May 4, 2012
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    DRF
    PMA / PMN Number
    K042775
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE INQUIRY STEERABLE 7F CATHETER WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED A KINK AND A PRESS MARK APPROXIMATELY 2.0 CM AND 5.3 CM RESPECTIVELY FROM THE CATHETER LOOP PLANE. FUNCTIONAL TESTING REVEALED THE CATHETER CREATED A CURVE; HOWEVER, THE CURVE DID NOT MATCH THE REQUIRED TEMPLATE DUE TO THE NOTED KINK. THE CATHETER DID NOT RETURN TO A NORMAL NON-DEFLECTIVE STATE. THE CATHETER WAS DISSECTED AT THE KINKED AREA REVEALING THAT THE ACTIVATION AND FLAT WIRES WERE BENT. THE CATHETER WAS ALSO DISSECTED AT THE LOCATION OF THE NOTED PRESS MARKS WHICH REVEALED THE INNER COMPONENTS WERE INTACT. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE OF THE REPORTED CATHETER REMOVAL DIFFICULTIES IS CONSISTENT WITH OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE ABLATION PROCEDURE, CATHETER REMOVAL DIFFICULTIES OCCURRED. THE PHYSICIAN COMPLETED ABLATION OF THE CAVO TRICUSPID ISTHMUS (CTI) LINE USING THE AFOCUS III CATHETER. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE AFOCUS II CATHETER THROUGH THE SL-1 SHEATH, THE SHAFT OF THE AFOCUS CATHETER BECAME ENTANGLED IN THE CATHETER LOOP AND COULD NOT BE REMOVED THROUGH THE SHEATH. THE PHYSICIAN REMOVED THE AFOCUS AND SJM SHEATH TOGETHER AS A UNIT TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INQUIRY AFOCUSII, 1120-7-4-SM-AF20DL CATHETER ELECTRODE RECORDING OR PROBE CATHETER DRF ST. JUDE MEDICAL, IRVINE 87008 3637275

    Patients

    Seq Age Sex Outcome Treatment
    1 SL-1 SHEATH: PRODUCT ID AND LOT # UNKNOWN