BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRODUCER

    MDR report key: 2489431 · Received March 8, 2012

    Report

    Report Number
    3005188751-2012-00089
    Event Type
    Injury
    Date Received
    March 8, 2012
    Date of Event
    February 27, 2012
    Report Date
    February 27, 2012
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 EVENT REMAINS UNK. A DHR REVIEW COULD NOT BE DONE, AS THE LOT NUMBER OF THE DEVICE IS UNK. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH 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

    THE SAME MFR REPORTS AS: 2030404-2012-00071, 2030404-2012-00072, 2030404-2012-00073 AND 3005188751-2012-00088. IT WAS REPORTED UPON COMPLETION OF A CARDIAC ABLATION PROCEDURE, THE PT DEVELOPED A PERICARDIAL EFFUSION. A SJM BRK NEEDLE AND AN UNK SJM INTRODUCER DEVICE WERE USED TO PERFORM TRANSSEPTAL PUNCTURE. AN AFOCUS II CATHETER AND AN INQUIRY QUADRI CATHETER WERE PLACED IN THE HEART. ABLATION WAS PERFORMED USING A COOL PATH DUO CATHETER. UPON COMPLETION OF THE PROCEDURE, THE PT BECAME HYPOTENSIVE AND AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED, 0.2 LITERS OF BLOOD WAS REMOVED FROM THE PERICARDIUM AND THE PT STABILIZED. THERE WERE NO FURTHER CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRODUCER INTRODUCER DYB ST. JUDE MEDICAL, AF DIVISION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention ONE SJM INQUIRY QUADRI CATHETER:| MODEL 81595, LOT 3560110| ONE SJM COOLPATH DUO CATHETER:| MODEL 81405, LOT 3543967| ONE SJM BRK NEEDLE: MODEL & LOT # UNK| ONE SJM AFOCUS II DECA CATHETER:| MODEL 83565, LOT 3430858