BEUDAMED
    FDA Adverse Event Summary report: N

    TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM

    MDR report key: 4870961 · Received June 26, 2015

    Report

    Report Number
    3005334138-2015-00081
    Date Received
    June 26, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 9, 2015
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    PMA / PMN Number
    P130026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE BATCH NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PERICARDIAL EFFUSION MAY HAVE BEEN PROCEDURE RELATED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 1

    DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. A TACTICATH QUARTZ ABLATION CATHETER WAS USED TO PERFORM ABLATION ON THE RIGHT ISTHMUS. AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION, WHICH REQUIRED NO INTERVENTION. THE PATIENT REMAINED STABLE AND RECOVERED WELL. THERE WERE NO PERFORMANCE ISSUES WITH THE TACTICATH QUARTZ ABLATION CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416722 TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM CARDIAC ABLATION PERCUTANEOUS CATHETER OAE ST. JUDE MEDICAL PN-004 075

    Patients

    Seq Age Sex Outcome Treatment
    1 Other