BEUDAMED
    FDA Adverse Event Death Summary report: N

    TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 65MM

    MDR report key: 7478947 · Received May 2, 2018

    Report

    Report Number
    9680001-2018-00042
    Event Type
    Death
    Date Received
    May 2, 2018
    Date of Event
    April 13, 2018
    Report Date
    May 14, 2018
    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
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICES WERE NOT RETURNED FOR ANALYSIS; HOWEVER, THE LOG FILES FROM THE TACTISYS QUARTZ SYSTEM WERE RETURNED. THE LOG FILE ANALYSIS CONCLUDED THAT THE TACTICATH CATHETER PERFORMED AS INTENDED. THE OPTICAL FIBERS MET SPECIFICATIONS, THE RECORDED TEMPERATURES INDICATED COOLING DURING RF ABLATION, AND CONTACT FORCE MEASUREMENTS WERE DISPLAYED THROUGHOUT THE DURATION OF THE LOG FILES. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE LOT NUMBERS ARE UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF DEATH WAS DUE TO AN AORTIC DISSECTION FROM THE NON-CORONARY CUSP. THE CAUSE OF THE DISSECTION REMAINS UNKNOWN.

    Description of Event or Problem · 1

    RELATED MANUFACTURING REF: 3005334138-2018-00114, 2030404-2018-00033, 2030404-2018-00034. FOLLOWING A POST RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) ABLATION PROCEDURE, THE PATIENT EXPIRED. DURING AN RVOT ABLATION PROCEDURE, TWO ABLATION CATHETERS WERE USED DUE TO DIFFICULTY REACHING THE SECOND ABLATION SITE. MAPPING OF THE RVOT AND AO WAS PERFORMED WITH ABLATION ONLY DONE IN THE RVOT. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS AND THE PATIENT WAS DISCHARGED HOME. THE PATIENT CONTACTED THE HOSPITAL WITH PAIN BETWEEN HER SHOULDER BLADES AND LATER EXPIRED. THE CAUSE OF DEATH WAS DUE TO AN AORTIC DISSECTION FROM THE NON-CORONARY CUSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322861 TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 65MM CARDIAC ABLATION PERCUTANEOUS CATHETER OAE VENUSA DE MEXICO S.A. DE C.V. PN-004 065 6188867

    Patients

    Seq Age Sex Outcome Treatment
    1 Death FLEXABILITY¿ ABLATION CATHETER, SE| INQUIRY¿ STEERABLE CATHETER