BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRK¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH

    MDR report key: 20136421 · Received September 4, 2024

    Report

    Report Number
    3008452825-2024-00502
    Event Type
    Death
    Date Received
    September 4, 2024
    Date of Event
    August 22, 2024
    Report Date
    September 24, 2024
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DRC
    UDI-DI
    05414734205139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: B5, H2, H6. ADDITIONAL INFORMATION: D9, G3, H2, H3, H6. AN EVENT OF CARDIAC TAMPONADE AND DEATH WAS REPORTED. 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 INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    RELATED MANUFACTURING REFERENCE: 3005334138-2024-00358. DURING A VENTRICULAR TACHYCARDIA PROCEDURE, A CARDIAC TAMPONADE OCCURRED AND THE PATIENT EXPIRED. WHILE PERFORMING THE TRANSSEPTAL APPROACH, THE PATIENT'S BLOOD PRESSURE DROPPED FROM 110 TO 40. AN ECHOCARDIOGRAM WAS DONE WHICH IDENTIFIED A CARDIAC TAMPONADE. A PERICARDIOCENTESIS AND TRANSFUSION WERE PERFORMED, A TOTAL OF 1.5L WAS DRAINED. DURING THE PERICARDIOCENTESIS, THE PATIENT WENT INTO CARDIAC ARREST. CARDIAC MASSAGE WAS DONE BUT WAS UNSUCCESSFUL AND THE PATIENT DECEASED. THE PHYSICIAN BELIEVED THAT THE AORTA WAS PERFORATED BY THE SHEATH AND DILATOR DURING THE TRANSSEPTAL APPROACH.

    Description of Event or Problem · 0

    THIS REPORT INCLUDES UPDATED DEVICE PROBLEM CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186044 BRK¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH TROCAR DRC ST. JUDE MEDICAL G407208 10404488 05414734205139

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death