BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSSEPTAL NEEDLE, BRK 1, 71CM

    MDR report key: 3954831 · Received July 17, 2014

    Report

    Report Number
    3005188751-2014-00086
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC (AF-MINNETONKA)
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATIONS ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR ANALYSIS WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PERICARDIAL EFFUSION WAS PROCEDURE RELATED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE IN THE HEART.

    Description of Event or Problem · 1

    DURING A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE USING A BRK TRANSSEPTAL NEEDLE, A PERICARDIAL EFFUSION OCCURRED. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BRK TRANSSEPTAL NEEDLE AND A PERICARDIAL EFFUSION WAS NOTED ON THE TRANSESOPHAGEAL ECHOCARDIOGRAM. NO PERICARDIOCENTESIS WAS REQUIRED. THE PROCEDURE WAS ABANDONED AND THE PATIENT RECOVERED TO REPEAT THE PROCEDURE THE FOLLOWING WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418815 TRANSSEPTAL NEEDLE, BRK 1, 71CM TRANSSEPTAL NEEDLE DRC ST. JUDE MEDICAL, INC (AF-MINNETONKA) 407201 4134271

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R