BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-L1-TE4BE1EB

    MDR report key: 3553429 · Received December 20, 2013

    Report

    Report Number
    2030404-2013-00120
    Event Type
    Injury
    Date Received
    December 20, 2013
    Date of Event
    November 28, 2013
    Report Date
    November 28, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-IRVINE)
    Product Code
    OAD
    PMA / PMN Number
    P110016/S008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PERICARDIAL EFFUSION WAS PROCEDURE RELATED. PER THE IFU, VASCULAR PERFORATION IS A KNOWN INHERENT RISK OF ANY ELECTRODE PLACEMENT.

    Description of Event or Problem · 1

    DURING AN ELECTROPHYSIOLOGY STUDY USING A THERAPY COOL FLEX ABLATION CATHETER, A PERICARDIAL EFFUSION OCCURRED. THE THERAPY COOL FLEX CATHETER WAS PLACED IN THE LEFT VENTRICLE VIA A RETROGRADE APPROACH. ALL DEVICES WERE REMOVED FROM THE HEART AT THE END OF THE STUDY AND COMPRESSION IN THE GROIN WAS APPLIED. AT THIS TIME, THE PATIENT BEGAN TO FEEL FAINT, DEVELOPED CHEST PAIN, AND BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZED THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669065 THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-L1-TE4BE1EB OAD ST. JUDE MEDICAL, INC. (AF-IRVINE) A088018 4262678

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention (B)(4)| (B)(4)| (B)(4)| ENSITE ARRAY CATHETER| FAST CATH TRANSSEPTAL INTRODUCER| FAST CATH TRANSSEPTAL INTRODUCER