BEUDAMED
    FDA Adverse Event Death Summary report: N

    TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 65MM

    MDR report key: 6191833 · Received December 20, 2016

    Report

    Report Number
    9680001-2016-00100
    Event Type
    Death
    Date Received
    December 20, 2016
    Date of Event
    November 23, 2016
    Report Date
    November 23, 2016
    Manufacturer
    VENUSA DE MEXICO S.A. DE C.V.
    Product Code
    OAE
    PMA / PMN Number
    P130026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS; HOWEVER, THE LOG FILES FROM THE TACTISYS QUARTZ SYSTEM WERE RETURNED. REVIEW OF THE LOG FILES REVEALED THE DEVICE FUNCTIONED AS INTENDED AND THERE WERE NO CONTRIBUTING ANOMALIES. FORCE MEASUREMENTS WERE RECORDED DURING ABLATION THAT EXCEEDED THE RECOMMENDED VALUES PER THE IFU; HOWEVER, DUE TO UNKNOWN PROCEDURAL CONDITIONS WE ARE UNABLE TO CONCLUSIVELY DETERMINE THE CAUSE OF THE REPORTED EVENT. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION WITH SJM SPECIFICATIONS AND PROCEDURES. THE CAUSE OF THE REPORTED PERFORATION COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK WITH THE USE OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING A PULMONARY VEIN ISOLATION PROCEDURE A PERICARDIAL EFFUSION OCCURRED. WHILE MAPPING IN THE LEFT ATRIUM THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION, FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. CHEST COMPRESSIONS WERE PERFORMED AND A PACING CATHETER WAS INSERTED INTO THE RIGHT VENTRICLE BUT NO MECHANICAL PUMPING OF THE HEART RETURNED AND THE PATIENT EXPIRED. THERE WERE NO PERFORMANCE ISSUES WITH THE SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840367 TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 65MM CARDIAC ABLATION PERCUTANEOUS CATHETER OAE VENUSA DE MEXICO S.A. DE C.V. PN-004 065 5420390

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death