BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPREME EP CATHETER 6F, QUADRIPOLAR, JSN

    MDR report key: 2383805 · Received December 14, 2011

    Report

    Report Number
    3005188751-2011-00230
    Event Type
    Injury
    Date Received
    December 14, 2011
    Date of Event
    November 16, 2011
    Report Date
    November 21, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIV.
    Product Code
    DRF
    PMA / PMN Number
    K894500
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL. THE PHYSICIAN ATTRIBUTED THE EVENT TO THE JSN CATHETER BASED ON LOCATION. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER 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

    IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED POST VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE. THE FOLLOWING DEVICES WERE USED DURING AN ISCHEMIC VT ABLATION PROCEDURE: AN ACROSS TRANSSEPTAL ACCESS SYSTEM, SL1 INTRODUCER, VIEWMATE ICE CATHETER PLACED IN THE RIGHT ATRIA, A CRD2 IN THE RIGHT ATRIA AT THE HIS LEVEL, DECAPOLAR AND SAFIRE ABLATION IN THE LEFT VENTRICLE AND THE SUPREME EP CATHETER IN THE RIGHT VENTRICLE. AT THE COMPLETION OF THE ABLATION PROCEDURE THE PT DID HAVE SLIGHT ST ELEVATION WHICH WAS ASSOCIATED WITH ABLATION OF SCAR AREAS. THE PT WAS TRANSFERRED TO A ROOM AFTER REMOVAL OF ALL DEVICES. THE PT PRESENTED WITH HYPOTENSION AND ST ELEVATION ON EKG A PERICARDIAL EFFUSION WAS CONFIRMED BY TRANSTHORACIC ECHOCARDIOGRAPHY. THE PT CODED AND REQUIRED SURGICAL INTERVENTION TO RESOLVE THE EFFUSION. THE CURRENT STATUS OF THE PT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPREME EP CATHETER 6F, QUADRIPOLAR, JSN CATHETER, ELECTRODE READING OR PROBE DRF ST. JUDE MEDICAL, AF DIV. 401451 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other CRD2 CATHETER (ALL ST. JUDE MEDICAL PRODUCTS,| SAFIRE ABLATION CATHETER ,| VIEWMATE ICE CATHETER,| SL1 INTRODUCER,| ACROSS TRANSSEPTAL ACCESS SYSTEM,| REORDER AND LOT NUMBERS UNK).