BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARIAT

    MDR report key: 1504660 · Received October 13, 2009

    Report

    Report Number
    3005802238-2009-00001
    Event Type
    Injury
    Date Received
    October 13, 2009
    Date of Event
    September 18, 2009
    Report Date
    October 8, 2009
    Manufacturer
    SENTREHEART INC.
    Product Code
    GAT
    PMA / PMN Number
    K090385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY -- A DETAILED INVESTIGATION OF THE EVENT WAS PERFORMED INCLUDING ANALYSIS OF THE RETURNED DEVICE, REVIEW OF IMAGES FROM THE PROCEDURE AND BENCH TESTING TO REPLICATE THE OBSERVED FAILURE. AFTER A REVIEW OF THE FLUORO IMAGES FROM THE PROCEDURE, IT APPEARED THAT THE USER ATTEMPTED TO FORCE OPEN THE SNARE AGAINST RESISTANCE WHICH WAS DUE IN PART TO THE POSITION OF THE DEVICE IN THE TISSUE. BENCH TESTING USING REPRESENTATIVE DEVICES WAS ABLE TO REPLICATE THE FAILURE MODE IN THE LAB. THE INVESTIGATION OF THE RETURNED DEVICE ITSELF DID NOT SUGGEST AN INHERENT DESIGN OR MANUFACTURING DEFECT CONTRIBUTED TO THE FAILURE. THE INVESTIGATION CONCLUDED THAT THE EVENT WOULD LIKELY HAVE BEEN AVOIDABLE HAD THE FOLLOWING OCCURRED: IDENTIFY THE POSITION OF THE LARIAT SNARE PRIOR AND AFTER CLOSURE TO CONFIRM NO ANATOMICAL STRUCTURE MAY CAUSE RESTRAINT OF THE SNARE OPENING; HAD THE SNARE ACTUATOR NOT BEEN FORCED OPEN LEADING TO THE FRACTURE OF THE SNARE ACTUATOR, IT IS BELIEVED THAT OPENING THE SNARE WHILE APPLYING LIGHT RETRACTION WOULD HAVE ALLOWED THE SNARE TO FULLY OPEN AND THE DEVICE COULD BE REMOVED SAFELY. THE CORRECTIVE ACTION FOR THIS EVENT WILL INCLUDE AN UPDATE TO THE LARIAT IFU TO ADD A PRECAUTION TO EXPLAIN HOW TO RECOGNIZE THE POTENTIAL FOR THIS EVENT AND WHAT TO DO SHOULD IT HAPPEN. ADDITIONALLY, AN IN-SERVICE TRAINING FOR CURRENT LARIAT USERS TO EXPLAIN HOW TO RECOGNIZE THE POTENTIAL FOR THIS EVENT AND WHAT TO DO SHOULD IT HAPPEN WILL BE PERFORMED. A COPY OF THE COMPLETE INVESTIGATION REPORT IS ON FILE AT SENTREHEART.

    Description of Event or Problem · 1

    THE LARIAT WAS USED TO LIGATE THE LEFT ATRIAL APPENDAGE. AFTER SUCCESSFUL LIGATION, THE PHYSICIAN ATTEMPTED TO OPEN THE SNARE TO REMOVE THE DEVICE. RESISTANCE WAS ENCOUNTERED TRYING TO OPEN THE SNARE. THE USER FORCEFULLY PUSHED AGAINST THE RESISTANCE CAUSING THE SNARE ACTUATOR TO BREAK INSIDE THE DEVICE. ATTEMPTS WERE MADE TO REMOVE THE DISCONNECTED SNARE FROM AROUND THE LAA AND WERE UNSUCCESSFUL. THE PATIENT WAS TRANSPORTED TO A SURGICAL SUITE. GENERAL ANESTHESIA HAD PREVIOUSLY BEEN ADMINISTERED. A SCOPE WAS ADVANCED THROUGH A THORASCOPIC INCISION AND A SURGICAL CUTTER WAS USED TO CUT THE LARIAT CATHETER APPROXIMATELY 1" PROXIMAL OF THE DISTAL TIP WHICH FREED THE SNARE. THE DEVICE WAS THEN REMOVED THROUGH THE ORIGINAL INCISION. AT 48 HOURS POST PROCEDURE, THE PHYSICIAN INDICATED THE PATIENT WAS DOING WELL, AND THERE IS NO CLINICAL SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARIAT SUTURE DELIVERY DEVICE GAT SENTREHEART INC. NA 70709029

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention