BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 7478943 · Received May 2, 2018

    Report

    Report Number
    3005334138-2018-00114
    Event Type
    Death
    Date Received
    May 2, 2018
    Date of Event
    April 13, 2018
    Report Date
    May 2, 2018
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAD
    PMA / PMN Number
    P110016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS 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: 9680001-2018-00042, 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
    322858 FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿ CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL A-FASE-DF

    Patients

    Seq Age Sex Outcome Treatment
    1 Death INQUIRY¿ STEERABLE CATHETER| INQUIRY¿ STEERABLE CATHETER| TACTICATH ABLATION CATHETER