BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH

    MDR report key: 8181088 · Received December 19, 2018

    Report

    Report Number
    3008452825-2018-00436
    Event Type
    Death
    Date Received
    December 19, 2018
    Date of Event
    November 29, 2018
    Report Date
    December 19, 2018
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA
    Product Code
    DRC
    UDI-DI
    05414734205184
    PMA / PMN Number
    K122587
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PATIENT EXPIRATION COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    RELATED MANUFACTURING REFERENCE: 9680001-2018-00186, 3008452825-2018-00435, 3005334138-2018-00512, 2182269-2018-00146, 3008452825-2018-00439. TWO DAYS FOLLOWING A PULMONARY VEIN ISOLATION PROCEDURE THE PATIENT EXPIRED. NO DEVICE PERFORMANCE ISSUES WERE NOTED THROUGHOUT THE PROCEDURE. POST ABLATION THE PATIENT WENT INTO ATRIAL FIBRILLATION AND WAS CARDIOVERTED. A TRANSESOPHAGEAL ECHO WAS PERFORMED REVEALING NO TAMPONADE OR CLOTS IN THE LEFT ATRIAL APPENDAGE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2018 AND EXPIRED (B)(6) 2018. A CORONER'S CT SCAN CONFIRMED THERE WAS NO TAMPONADE, CLOTS, OR ESOPHAGEAL INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020748 BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH TRANSSEPTAL NEEDLE DRC ST. JUDE MEDICAL, COSTA RICA LTDA G407209 6617308 05414734205184

    Patients

    Seq Age Sex Outcome Treatment
    1 Death AGILIS¿ NXT STEERABLE INTRODUCER| FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER| INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER| REFLEXION¿ SPIRAL CATHETER| TACTICATH¿ QUARTZ ABLATION CATHETER