BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBRA FUSION 150 ABLATION SYSTEM

    MDR report key: 3912929 · Received June 10, 2014

    Report

    Report Number
    2953686-2014-00008
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 2, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ENDOSCOPIC TECHNOLOGIES
    Product Code
    OCL
    PMA / PMN Number
    K113475
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER HAS REQUESTED THE DEVICE BACK FROM THE HEALTHCARE FACILITY. DEVICE HISTORY RECORDS WERE REVIEWED. PICTURE OF DEVICE SENT TO MANUFACTURER WAS REVIEWED AND SHOWED EXTREME MANIPULATION WHERE THE COMPONENT ASSEMBLY WAS TORN. INSTRUCTION FOR USE INSTRUCTS THE USER ONLY TO GRASP AT THE DISTAL OR PROXIMAL ENDS, AWAY FROM THE ELECTRODES.

    Description of Event or Problem · 1

    AORTIC VALVE REPLACEMENT WITH SUBSEQUENT USE OF ABLATION SYSTEM. DURING THE PLACEMENT OF THE ABLATION CATHETER, THERE WAS A PERFORATION ON THE LEFT ATRIUM THROUGH A SHARP, BENT ELECTRODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338181 COBRA FUSION 150 ABLATION SYSTEM COBRA FUSION 150 ABLATION SYSTEM OCL ENDOSCOPIC TECHNOLOGIES 700-001S 12948-120213

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention