BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARIAT SUTURE DELIVERY DEVICE

    MDR report key: 2960263 · Received February 8, 2013

    Report

    Report Number
    3005802238-2013-00003
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 10, 2013
    Report Date
    February 8, 2013
    Manufacturer
    SENTREHEART INC.
    Product Code
    GAT
    PMA / PMN Number
    K090385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WAS PROVIDED BY THE SENTREHEART REP WHO ATTENDED THE CASE. THE LIGATION PROCEDURE ITSELF WAS UNREMARKABLE AND WAS COMPLETED WITH NO UNUSUAL CIRCUMSTANCES. THE SURGEON NOTED THAT THE LACERATION WAS FOUND ON A SECONDARY LOBE OF THE APPENDAGE THAT WAS SOME DISTANCE AWAY FROM THE SUTURE DEPLOYED FROM THE LARIAT. THE TREATING PHYSICIAN COMMENTED THAT HE HAD NOT SEEN THE LOBE DURING THE COURSE OF THE PROCEDURE. THE CAUSE OF THE LACERATION WAS UNKNOWN. THE PT THEN RECOVERED NORMALLY WITH NO FURTHER SEQUELAE. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THERE IS NO EVIDENCE TO SUGGEST THERE WAS A DEVICE MALFUNCTION. A REVIEW OF MFG RECORDS CONFIRMED THE DEVICE MET SPECIFICATIONS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    THE LARIAT WAS USED TO LIGATE THE LAA ON A (B)(6) FEMALE. FOLLOWING A SUCCESSFUL LIGATION, AN EFFUSION WAS OBSERVED ON BOTH ECHO AND FLUORO. PERICARDIOCENTESIS WAS THEN PERFORMED TO MANAGE THE EFFUSION, BUT WAS FOLLOWED BY A SUDDEN DROP IN BLOOD PRESSURE. THE PHYSICIAN THEN DECIDED TO SEND THE PT TO SURGERY. THE SURGEON PERFORMED A MEDIAN STERNOTOMY AND REPORTED A LACERATION IN A SECONDARY LOBE OF THE LAA THAT HAD NOT BEEN CAPTURED. THE LACERATION WAS SUBSEQUENTLY SUTURED AND THE BLEEDING RESOLVED. PT WAS REPORTED STABLE THE FOLLOWING DAY AND EXPECTED TO RECOVER NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53516 LARIAT SUTURE DELIVERY DEVICE REMOTE SUTURE DELIVERY DEVICE GAT SENTREHEART INC. NA 70512015

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention