BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPONSE EP CATHETER, 6F, DECAPOLAR, CSL

    MDR report key: 1833539 · Received August 16, 2010

    Report

    Report Number
    3005188751-2010-00079
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 20, 2010
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DRF
    PMA / PMN Number
    K002976
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE WERE UNABLE TO EVALUATE THE PRODUCT INVOLVED IN THIS INCIDENT SINCE NO COMPONENTS OF THE DEVICE WERE RETURNED FOR ANALYSIS. BASED ON THE INFO PROVIDED TO ST JUDE MEDICAL, THE CAUSE FOR THE REPORTED PERICARDIAL EFFUSION REMAINS UNK. AS THE LOT NUMBER FOR THE DEVICES IS UNK, REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A TRANSSEPTAL PUNCTURE WAS PERFORMED USING A SJM BRK NEEDLE IN PREPARATION FOR A PULMONARY VEIN ISOLATION PROCEDURE. THE CS RESPONSE CATHETER WAS PLACED IN THE CORONARY SINUS. GEOMETRY IN THE LEFT ATRIUM WAS OBTAINED USING A SJM SPIRAL CATHETER AND THE COOL PATH ABLATION CATHETER. DURING THE FUSION PROCESS, IT WAS NOTICED THAT THERE WAS A DECREASE IN THE PT'S BLOOD PRESSURE. ECHOCARDIOGRAPHY CONFIRMED AN EFFUSION AND A PERICARDIOCENTESIS WAS PERFORMED. THE CASE ENDED IMMEDIATELY. APPROXIMATELY 3 HOURS LATER, THE PT UNDERWENT SURGERY DUE TO THE EFFUSION. THE PHYSICIAN WAS UNSURE OF THE CAUSE FOR THE EFFUSION AND DID NOT ATTRIBUTE THE EVENT TO THE SJM PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPONSE EP CATHETER, 6F, DECAPOLAR, CSL RESPONSE EP, 6F, DECA DRF ST. JUDE MEDICAL, AF DIVISION 401353 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other