BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIPLE

    MDR report key: 1192723 · Received October 6, 2008

    Report

    Report Number
    2030404-2008-00013
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 16, 2008
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NONE OF THE DEVICES WERE RETURNED FOR ANALYSIS AND REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNK. THE CAUSE FOR THE REPORTED PERICARDIAL EFFUSION AND SUBSEQUENT PERICARDIOCENTESIS REMAIN UNK. IT SHOULD BE NOTED THAT THE PHYSICIAN DOES NOT ALLEGE THE EFFUSION WAS CAUSED BY ANY SJM PRODUCTS. IN ADDITION, THE INSTRUCTIONS FOR USE (IFU) STATES THAT VASCULAR PERFORATION IS AN INHERENT RISK OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE USING NAVX, A PERFORATION OCCURRED. MULTIPLE DEVICES WERE USED DURING THE PROCEDURE. THE PHYSICIAN USED BOTH AN AGILIS AND SR0 SHEATH TRANSEPTALLY, AND PERFORMED AN AF ABLATION USING THE COOL PATH CATHETER ((B)(4)). A BRK NEEDLE ((B)(4), LOT UNK) AND ACUSON INTRACARDIAC ECHO ((B)(4)) WERE USED FOR THE TRANSSEPTAL PUNCTURE. AFTER PERFORMING THE LEFT ATRIAL ABLATION, IT WAS NOTED ON ICE THAT THE PATIENT HAD A PERICARDIAL EFFUSION AND A PERICARDIOCENTESIS WAS PERFORMED. THE HEPARIN WAS RUNNING AT 4000 UNITS/HOUR WHICH TURNED OFF ONE HOUR PRIOR TO FINDING THE EFFUSION. AT THE TIME THE HEPARIN WAS TURNED OFF, THE ACT WAS 284. IT SHOULD BE NOTED THAT THE PHYSICIAN DOES NOT ALLEGE THE EFFUSION WAS CAUSED BY ANY SJM PRODUCTS,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIPLE NONE UNK ST JUDE MEDICAL MULTIPLE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other SJM INQUIRY STIRABLE QUAD: (B)(4)| SJM SL0 SHEATH (B)(4), LOT: 2075301| SJM THERAPY COOL PATH CATHETER: (B)(4)| SJM DECA 2-8-2 SPACING: (B)(4)| SJM ENSITE SYSTEM NAVX W/FUSION| BWI LASSO: (B)(4)| COOK EXCHANGE WIRE: (B)(4)| HEPARIN