BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2113528 · Received June 1, 2011

    Report

    Report Number
    2030404-2011-00142
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE IN THE PROCESS OF EVALUATING THIS DEVICE. WHEN OUR INVESTIGATION HAS BEEN COMPLETED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, A TAMPONADE OCCURRED. IT WAS NOTED THE CATHETER HAD A SLIGHT BEND WHEN REMOVED FROM THE PT. THE PHYSICIAN WAS MOVING THE CATHETER INSIDE THE ATRIUM CLOSE TO THE LEFT APPENDAGE WHEN THE PERFORATION WAS NOTED. AN ECHO CARDIOGRAM WAS CONDUCTED AND THE PHYSICIAN OBSERVED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED. THE PT FELT FAINT AFTER THE PROCEDURE, BUT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-L-TE4BE1EB CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, IRVINE 88016 3266202

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention RESPONSE 10POLS CSL: (B)(4)| SWART SL0: (B)(4)| IBI OPTIMA 10 POLE: (B)(4)