BEUDAMED
    FDA Adverse Event Death Summary report: N

    SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 63 CM LENGTH, 8.5 F

    MDR report key: 8686266 · Received June 11, 2019

    Report

    Report Number
    3005334138-2019-00301
    Event Type
    Death
    Date Received
    June 11, 2019
    Date of Event
    May 27, 2019
    Report Date
    June 11, 2019
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K052644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 THE REPORTED EDEMA AND SUBSEQUENT DEATH REMAIN UNKNOWN.

    Description of Event or Problem · 1

    RELATED MANUFACTURE REF: 3005334138-2019-00300, 2030404-2019-00043, 2030404-2019-00044, 3008452825-2019-00269. ONE DAY POST ATRIAL FIBRILLATION PROCEDURE, THE PATIENT EXPERIENCED ACUTE PULMONARY EDEMA AND EXPIRED. THE PATIENT HAD A HISTORY OF HEART FAILURE, THE CAUSE OF PULMONARY EDEMA IS UNKNOWN, THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482640 SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 63 CM LENGTH, 8.5 F INTRODUCER, CATHETER DYB ST. JUDE MEDICAL 407451

    Patients

    Seq Age Sex Outcome Treatment
    1 Death BRK XS TRANSSEPTAL NEEDLE| INQUIRY OPTIMA PLUS CATHETER| INQUIRY STEERABLE CATHETER| TACTICATH SE ABLATION CATH