BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFIRE BI-DIRECTIONAL ABLATION CATH., 7F, LRG CRL

    MDR report key: 3812500 · Received May 5, 2014

    Report

    Report Number
    3005188751-2014-00072
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-MINNETONKA)
    Product Code
    LPB
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A RIGHT ATRIAL FLUTTER ABLATION PROCEDURE USING A SAFIRE ABLATION CATHETER, A CARDIAC TAMPONADE OCCURRED. ABLATION WAS BEING PERFORMED ON THE CAVOTRICUSPID ISTHMUS WITH A SAFIRE ABLATION CATHETER AND AN AUDIBLE STEAM POP WAS NOTED. THE PATIENT BECAME DYSPNEIC AND REDUCED MOVEMENT OF THE CARDIAC SILHOUETTE WAS NOTED VIA FLUOROSCOPY. AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. THE PATIENT WAS TRANSFERRED TO SURGERY FOR A SUCCESSFUL REPAIR OF THE CARDIAC PERFORATION AND WAS IN STABLE CONDITION. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267920 SAFIRE BI-DIRECTIONAL ABLATION CATH., 7F, LRG CRL CATHETER, PERCUTANEOUS CARDIAC ABLATION LPB ST. JUDE MEDICAL, INC. (AF-MINNETONKA) 402829 4422599

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention LIVEWIRE DUO-DECA EP CATHETER (MODEL/LOT UNK)