BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3022750 · Received March 22, 2013

    Report

    Report Number
    2030404-2013-00017
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-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

    ONE THERAPY ABLATION COOL FLEX CATHETER WAS RECEIVED FOR COMPLAINT EVALUATION. THERE WERE NO VISIBLE ANOMALIES NOTED. FUNCTIONAL TESTING REVEALED THE CATHETER MET ALL SPECIFICATIONS. THE CATHETER TIP WAS INVESTIGATED UNDER THE MICROSCOPE, WHICH IDENTIFIED NO ANOMALIES. THE DEVICE ALSO MET SPECIFICATIONS PRIOR TO RELEASE FROM SJM MANUFACTURING FACILITIES AS SUPPORTED BY THE DEVICE HISTORY RECORD. THE CAUSE OF THE REPORTED STEAM POP REMAINS UNKNOWN. THE IFU WARNS THE USER THAT VASCULAR PERFORATION IS AN INHERENT RISK OF ANY ELECTRODE PLACEMENT.

    Description of Event or Problem · 1

    DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE USING A THERAPY COOL FLEX ABLATION CATHETER, A STEAM POP FOLLOWED BY A CARDIAC TAMPONADE OCCURRED. THE PHYSICIAN WAS PERFORMING ABLATION ON THE ANTERIOR PORTION OF THE LEFT ATRIUM WHEN A STEAM POP WAS HEARD BY THE STAFF. THE PATIENT BECAME HYPOTENSIVE AND AN ECHOCARDIOGRAM REVEALED A CARDIAC TAMPONADE. THE PHYSICIAN ATTEMPTED A PERICARDIOCENTESIS, WHICH WAS INSUFFICIENT TO RESOLVE THE TAMPONADE; THEREFORE, OPEN HEART SURGERY WAS PERFORMED TO SUCCESSFULLY TREAT THE TAMPONADE. THE PATIENT WAS STABILIZED AND IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119503 THERAPY COOL FLEX, 1304-CF-7-0.5(2)2-L-TE4BE1EB CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, INC. (AF-IRVINE) A088016 38794591

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention BRK NEEDLE: MODEL 407200, LOT 3885847| SWARTZ SL0 INTRODUCER| INQUIRY AFOCUS II: MODEL 81595, LOT 38595371| INQUIRY STEERABLE: MODEL 81104, LOT 3893050| COOL POINT PUMP| IBI T11 GENERATOR