BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-M-TE4BE1EB

    MDR report key: 3093788 · Received April 30, 2013

    Report

    Report Number
    2030404-2013-00036
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-IRVINE)
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED STEAM POP AND RESULTANT PERICARDIAL EFFUSION COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, VASCULAR PERFORATION IS AN INHERENT RISK OF ANY ELECTRODE PLACEMENT.

    Description of Event or Problem · 1

    DURING A RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) ABLATION PROCEDURE USING A THERAPY COOL FLEX ABLATION CATHETER, A PERICARDIAL EFFUSION OCCURRED. WHILE ABLATING THE RVOT, THE PHYSICIAN HEARD A STEAM POP AND CEASED RF DELIVERY. THE PT BECAME HYPOTENSIVE AND THE PHYSICIAN PERFORMED A PERICARDIOCENTESIS, WHICH STABILIZED THE PT. THE PHYSICIAN CONTINUED THE ABLATION PROCEDURE FOR A VENTRICULAR TACHYCARDIA (VT) WITH A DIFFERENT MORPHOLOGY. THE PT LEFT THE LAB IN STABLE CONDITION WITH A PERICARDIAL RAIN IN PLACE. THE PT REMAINED IN THE HOSPITAL WITH RECURRENT VT, FOR WHICH ANOTHER ABLATION PROCEDURE HAS BEEN SCHEDULED. THE PHYSICIAN DOES NOT ALLEGE ANY PERFORMANCE ISSUES WITH ANY SJM DEVICE USED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187487 THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-M-TE4BE1EB CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, INC. (AF-IRVINE) A088015 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention AGILIS INTRODUCER (408310/LOT UNK)| BIOSENSE WEBSTER COOLFLOW IRRIGATION PUMP| BIOSENSE WEBSTER STOCKERT GENERATOR