BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARIAT SUTURE DELIVERY DEVICE

    MDR report key: 3057237 · Received April 10, 2013

    Report

    Report Number
    3005802238-2013-00004
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 11, 2013
    Report Date
    April 10, 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 TREATING PHYSICIAN COMMENTED THAT HE THOUGHT THE EXTRA MANIPULATION OF THE DEVICE REQUIRED IN PART BECAUSE OF THE LARGE SIZE OF THE PT MAY HAVE CONTRIBUTED TO THE EVENT. THE LARIAT MOVED UNEXPECTEDLY WHILE THE ENDOCARDIAL FINDRWIRE WAS REMOVED. THIS MAY HAVE PULLED ON THE FRIABLE LAA TISSUE CAUSING A TEAR/LACERATIONS WERE LOCATED OFF THE NECK OF THE APPENDAGE, APPROXIMATELY ON THIRD TOWARDS THE APEX. THE EXACT CAUSE OF THE LACERATION IS UNK. 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

    LAA LIGATION WITH LARIAT WAS ATTEMPTED ON (B)(6) MALE. A SIGNIFICANT AMOUNT OF ADD'L MANIPULATION OF THE LARIAT WAS REQUIRED TO CAPTURE THE LAA DUE TO A COMBINATION OF THE PT'S ANATOMY AND ABDOMINAL SIZE ((B)(6)). ONCE THE LAA WAS CAPTURED, BUT PRIOR TO DEPLOYMENT OF THE SUTURE, THE DOCTOR NOTICED THE LARIAT MOVE UNEXPECTEDLY. SHORTLY THEREAFTER, AN EFFUSION WAS OBSERVED ON ECHO. PERICARDIOCENTESIS WAS THEN PERFORMED TO MANAGE THE EFFUSION WHILE THE PT REMAINED STABLE. THE DOCTOR DECIDED TO SEND THE PT TO SURGERY WHERE THE LAA WAS THEN EXCISED SURGICALLY. PT WAS REPORTED STABLE THE FOLLOWING DAY AND EXPECTED TO RECOVER NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149619 LARIAT SUTURE DELIVERY DEVICE REMOTE SUTURE DELIVERY DEVICE GAT SENTREHEART INC. NA 71012057

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention