BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL PATH CATHETER 7F, 1304-CP-7-25-M-AB

    MDR report key: 2229505 · Received August 15, 2011

    Report

    Report Number
    2030404-2011-00238
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION BY MANUFACTURER: ONE COOL PATH 7F CATHETER WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED CHAR ON THE DISTAL TIP. FUNCTIONAL TESTING OF THE DEVICE CONFIRMED THE CATHETER PASSED CONTINUITY, RESISTANCE AND EKG TESTING. STEERING FORCE TO CREAT A CURVE WAS WITHIN SPECIFICATION CRITERIA. THE CATHETER ALSO SUCCESSFULLY PASSED THE PRESSURE DROP, FLOW AND ABLATION SIMULATION TEST. THE THERMO-SYSTEM WAS VERIFIED WITH NO ISSUE. MICROSCOPIC INSPECTION OF THE DISTAL TIP REVEALED NO ANOMALIES. THE CATHETER MET ALL INSPECTION CRITERIA. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE ABLATING WITH THE COOL PATH ABLATION CATHETER A STEAM POP OCCURRED AND CHAR WAS NOTED ON THE DISTAL ELECTRODE. THE PHYSICIAN NOTED WHILE UNPACKING THE COOL PATH IRRIGATED ABLATION CATHETER THAT THE CATHETER "LOOKED DIFFERENT". THE PATIENT HAD PERSISTENT ATRIAL FIBRILLATION REQUIRING COMPLEX FRACTIONATED ELECTROGRAM (CFE) ABLATION. WHILE ABLATING IN THE CORONARY SINUS OSTIUM WITH THE COOL PATH CATHETER AND USING ABLATION SETTINGS OF 48 DEGREES CELSIUS, 30-35 WATTS, WITH A FLOW RATE OF 30ML/MIN, A STEAM POP OCCURRED. THE CATHETER WAS REMOVED FROM THE PATIENT AND CHARRING WAS NOTED ON THE DISTAL ELECTRODE. THERE WERE NO CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH CATHETER 7F, 1304-CP-7-25-M-AB NONE OAD ST. JUDE MEDICAL, IRVINE 83503 3290653

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR