BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIVEWIRE EP CATHETER, 5F, DECA, 115CM XTRA LRG CRL

    MDR report key: 1757026 · Received July 13, 2010

    Report

    Report Number
    3005188751-2010-00062
    Event Type
    Other
    Date Received
    July 13, 2010
    Date of Event
    June 16, 2010
    Report Date
    June 17, 2010
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DRF
    PMA / PMN Number
    K022380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE WERE UNABLE TO EVALUATED THE PRODUCTS INVOLVED IN THIS INCIDENT SINCE NO COMPONENTS WERE RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER FOR THE DEVICE IS UNK. BASED ON THE INFO PROVIDED TO ST. JUDE MEDICAL, THE CAUSE FOR THE REPORTED PERFORATION REMAINS UNK. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 HOURS INTO AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE PT'S BLOOD PRESSURE DROPPED AND A PERFORATION WAS NOTED IN THE LEFT ATRIUM. THE FLUID WAS DRAINED AND THE PT STABILIZED. A THERAPY COOL PATH ABLATION CATHETER AND LIVEWIRE EP CATHETER WERE IN THE HEART WHEN THE EFFUSION WAS NOTICED. THE PHYSICIAN COULD NOT DETERMINE THE CAUSE OF THE EFFUSION AND DOES NOT ALLEGE ANY SJM PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIVEWIRE EP CATHETER, 5F, DECA, 115CM XTRA LRG CRL LIVEWIRE EP 5F, DECA DRF ST. JUDE MEDICAL, AF DIVISION 401991 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other