BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRK¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH

    MDR report key: 8686270 · Received June 11, 2019

    Report

    Report Number
    3008452825-2019-00269
    Event Type
    Death
    Date Received
    June 11, 2019
    Date of Event
    May 27, 2019
    Report Date
    June 11, 2019
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA
    Product Code
    DRC
    PMA / PMN Number
    K122587
    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 MANUFACTURING REF: 3005334138-2019-00300, 3005334138-2019-00301, 2030404-2019-00043, 2030404-2019-00044. 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
    482362 BRK¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH TROCAR DRC ST. JUDE MEDICAL, COSTA RICA LTDA G407208

    Patients

    Seq Age Sex Outcome Treatment
    1 Death INQUIRY OPTIMA PLUS CATHETER| INQUIRY STEERABLE CATHETER| SWARTZ BRAIDED INTRODUCER| TACTICATH SE ABLATION CATH