BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINDRWIRZ

    MDR report key: 3687505 · Received March 11, 2014

    Report

    Report Number
    3005802238-2014-00003
    Event Type
    Injury
    Date Received
    March 11, 2014
    Date of Event
    February 12, 2014
    Report Date
    March 11, 2014
    Manufacturer
    SENTREHEART INC.
    Product Code
    DQX
    PMA / PMN Number
    K080364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL AND THEREFORE IS NO EVIDENCE TO SUGGEST THERE WAS A DEVICE MALFUNCTION. A REVIEW OF MANUFACTURING RECORDS CONFIRMED THE DEVICE MET SPECIFICATIONS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    THE LARIAT WAS BEING USED TO LIGATE THE LEFT ATRIAL APPENDAGE. AN EFFUSION DEVELOPED ALONG WITH A DROP IN BLOOD PRESSURE SHORTLY AFTER AN ATTEMPT TO CAPTURE THE LAA. A DRAIN WAS IMMEDIATELY PLACED FOLLOWED BY A TRANSFUSION. THE BLEEDING WAS RESOLVED SURGICALLY. THE PT WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145779 FINDRWIRZ GUIDEWIRE DQX SENTREHEART INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention