BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INQUIRY STEERABLE CATH. 6F, 1110-6-25-L

    MDR report key: 2780539 · Received October 5, 2012

    Report

    Report Number
    2030404-2012-00265
    Event Type
    Injury
    Date Received
    October 5, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    DRF
    PMA / PMN Number
    K961924
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. A DHR COULD NOT BE DONE AS THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFO PROVIDED TO ST. JUDE MEDICAL, THE CAUSE FOR THE REPORTED EVENT REMAINS UNK. HOWEVER, THE MOST LIKELY ROOT CAUSE CLASSIFICATION CONSISTENT THE REPORTED EVENT IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE IFU.

    Description of Event or Problem · 1

    SAME EVENT AS MFR #'S: 3005188751-2012-00269, 00270, 00271, 2030404-2012-00264, 00266. IT WAS REPORTED DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE A PERICARDIAL EFFUSION OCCURRED. THE PHYSICIAN PERFORMED AN ABLATION USING TWO SJM FAST-CATH INTRODUCERS, A SJM BRK NEEDLE FOR TRANSSEPTAL PUNCTURE, A SJM COOL PATH ABLATION CATHETER, A SJM INQUIRY STEERABLE EP CATHETER AND A SJM INQUIRY OPTIMA STEERABLE EP CATHETER. AT THE COMPLETION OF THE PROCEDURE, THE PHYSICIAN REMOVED ALL CATHETERS FROM THE PT TO VERIFY THE SILHOUETTE OF THE HEART FOR HEART FUNCTION BY MOVEMENT UNDER FLUOROSCOPY. THE PHYSICIAN NOTICED THE HEART DID NOT MOVE WITH NORMAL MOVEMENT AND THE PT'S BLOOD PRESSURE DECREASED. AN ECHOCARDIOGRAM WAS DONE AND CONFIRMED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO RESOLVE THE EFFUSION. NO FURTHER INTERVENTION WAS REQUIRED. THE PT CONDITION WAS LISTED AS STABLE. ADD'L INFO WAS REQUESTED BUT NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INQUIRY STEERABLE CATH. 6F, 1110-6-25-L ELECTRODE RECORDING CATHETER DRF ST. JUDE MEDICAL, IRVINE 81104 3739581

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOT 3739581)| FAST-CATH INTRODUCER (MODEL 406948, LOT UNK)| BRK TRANSSEPTAL NEEDLE (MODEL G407208, LOT UNK)| LOT 3588891)| INQUIRY STEERABLE EP CATHETER (MODEL 81104,| INQUIRY OPTIMA STEERABLE EP CATHETER| (MODEL 81687, LOT 3500949)| COOL PATH ABLATION CATHETER (MODEL 83503,