BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINDRWIRZ

    MDR report key: 3911592 · Received May 27, 2014

    Report

    Report Number
    3005802238-2014-00007
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 28, 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 EVALUATION AND THERE 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 A LARGE LEFT ATRIAL APPENDAGE. THE PHYSICIAN ENCOUNTERED SOME DIFFICULTY ADVANCING THE LARIAT OVER THE LAA DUE TO ITS SIZE. A PERFORATION OF THE LAA BY THE WIRE OCCURRED WHEN THE PHYSICIAN ATTEMPTED TO FURTHER ADVANCE THE LARIAT TOWARDS THE BASE OF THE LAA TO FULLY CAPTURE IT. AS SUCH, AN EFFUSION DEVELOPED. THE PATIENT WAS CONVERTED TO SURGERY. THE LAA WAS LIGATED SURGICALLY AND THE BLEEDING RESOLVED. THE PATIENT WAS REPORTED TO BE STABLE AND DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311664 FINDRWIRZ GUIDEWIRE DQX SENTREHEART INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention