BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSSEPTAL NEEDLE, BRK-1 ADULT 18GA., 98CM

    MDR report key: 3911582 · Received May 27, 2014

    Report

    Report Number
    3005188751-2014-00076
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    ST. JUDE MEDICAL (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 INVESTIGATION 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 TRANSSEPTAL TECHNIQUE.

    Description of Event or Problem · 1

    DURING PULMONARY VEIN ISOLATION PROCEDURE USING A BRK TRANSSEPTAL NEEDLE, A PERICARDIAL EFFUSION OCCURRED. TRANSEPTAL PUNCTURE WAS PERFORMED WITH A BRK TRANSEPTAL NEEDLE AND AN AGILIS NXT INTRODUCER AND A SWARTZ BRAIDED TRANSSEPTAL INTRODUCER WERE ADVANCED INTO THE LEFT ATRIUM. A NON-SJM LASSO CATHETER AND A TACTICATH QUARTZ ABLATION CATHETER WERE THEN PLACED IN THE LEFT ATRIUM. A PERICARDIAL EFFUSION WAS NOTED VIA FLUOROSCOPY EARLY IN THE CASE; HOWEVER, ABLATION WAS ABLE TO BE COMPLETED ON THE LEFT INFERIOR AND SUPERIOR PULMONARY VEINS. ABLATION HAD BEGUN ON THE RIGHT PULMONARY VEINS WHEN THE PATIENT'S VITAL SIGNS BECAME UNSTABLE. AN ECHOCARDIOGRAM CONFIRMED THE PERICARDIAL EFFUSION AND A PERICARDIOCENTESIS WAS PERFORMED, WHICH STABILIZED THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311409 TRANSSEPTAL NEEDLE, BRK-1 ADULT 18GA., 98CM TRANSSEPTAL NEEDLE DRC ST. JUDE MEDICAL (AF-MINNETONKA) 407207 4400042

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention