BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAPY? COOL PATH ? DUO ABLATION CATHETER

    MDR report key: 4307389 · Received December 9, 2014

    Report

    Report Number
    2030404-2014-00102
    Event Type
    Injury
    Date Received
    December 9, 2014
    Date of Event
    November 11, 2014
    Report Date
    November 11, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    OAD
    PMA / PMN Number
    PP110016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 CARDIAC TAMPONADE MAY HAVE BEEN PROCEDURE RELATED. PER THE IFU, VASCULAR PERFORATION IS AN INHERENT RISK OF ANY ELECTRODE PLACEMENT.

    Description of Event or Problem · 1

    DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE USING A THERAPY COOL PATH DUO ABLATION CATHETER, A CARDIAC TAMPONADE OCCURRED. A THERAPY COOL PATH DUO ABLATION CATHETER WAS ADVANCED VIA RETROGRADE APPROACH AND MAPPING WAS PERFORMED IN THE LEFT VENTRICLE. THE CATHETER WAS THEN NOTED TO BE IN THE EPICARDIAL SPACE AND THE PATIENT BECAME HYPOTENSIVE AND DIAPHORETIC. AN ECHOCARDIOGRAM REVEALED A CARDIAC TAMPONADE AND A PERICARDIOCENTESIS WAS PERFORMED, WHICH STABILIZED THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793835 THERAPY? COOL PATH ? DUO ABLATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, INC. 83563 4485831

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LIVEWIRE EP CATHETER| AGILIS NXT INTRODUCER| SUPREME EP CATHETER