BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRANSSEPTAL NEEDLE, BRK SERIES, ADULT 18 GA, 71CM

    MDR report key: 2629636 · Received June 20, 2012

    Report

    Report Number
    3005188751-2012-00174
    Event Type
    Death
    Date Received
    June 20, 2012
    Date of Event
    June 2, 2012
    Report Date
    June 12, 2012
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH ANTICIPATED PROCEDURAL COMPLICATIONS AS A PERICARDIAL EFFUSION IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE IFU.

    Description of Event or Problem · 1

    SAME CASE AS MFR #3005188751-2012-00173. IT WAS REPORTED DURING A LEFT ATRIAL APPENDAGE TRANSCATHETER OCCLUSION PROCEDURE THE PATIENT DEVELOPED A PERICARDIAL EFFUSION AND SUBSEQUENTLY DIED. A SJM FAST-CATH INTRODUCER AND SJM BRK NEEDLE WERE USED TO PERFORM TRANSSEPTAL PUNCTURE. DURING THE DIAGNOSTIC PHASE OF THE PROCEDURE, INJECTIONS WITH CONTRAST WERE DONE THROUGH THE FAST-CATH INTRODUCER. DURING THE LAST INJECTION, A PERICARDIAL EFFUSION WAS NOTED. A PERICARDIOCENTESIS WAS PERFORMED IN ORDER TO KEEP THE BLOOD PRESSURE STABLE. EMERGENCY PROCEDURES WERE DONE AND THE PATIENT BECAME INCREASINGLY HYPOTENSIVE. AFTER SEVEN HOURS THE PATIENT DIED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSSEPTAL NEEDLE, BRK SERIES, ADULT 18 GA, 71CM TRANSSEPTAL NEEDLE DRC ST. JUDE MEDICAL, AF DIVISION 407200 3558126

    Patients

    Seq Age Sex Outcome Treatment
    1 Death LOT 3626073| FAST-CATH TRANSSETAL INTRODUCER: MODEL 407436