BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOFTIP

    MDR report key: 5962211 · Received September 20, 2016

    Report

    Report Number
    3005802238-2016-00004
    Event Type
    Death
    Date Received
    September 20, 2016
    Date of Event
    March 16, 2016
    Manufacturer
    SENTREHEART, INC.
    Product Code
    GAT
    PMA / PMN Number
    K090385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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. IT APPEARS THAT THE CHALLENGING ANATOMY CONTRIBUTED TO THE MULTIPLE ATTEMPTS BY THE PHYSICIAN TO SNARE THE LAA AND THAT SUCH EVENTS MAY HAVE CAUSED THE DAMAGE TO THE RIGHT VENTRICLE. THE SUBSEQUENT SURGERY CONTRIBUTED TO THE ALREADY COMPROMISED PATIENT'S HEALTH. DEVICE DISCARDED BY HOSPITAL.

    Description of Event or Problem · 1

    THE LARIAT WAS USED TO LIGATE THE LAA PER THE PHYSICIAN'S DISCRETION. DURING THE PROCEDURE, THE PHYSICIAN NOTICED CHALLENGING ANATOMY AT THE BASE OF THE LAA/LA IN THE SHAPE OF A CAULIFLOWER. THE PHYSICIAN ELECTED TO PROCEED GIVEN THAT ANOTHER DEVICE WOULD NOT LIKELY ADDRESS THIS TYPE OF LAA/LA SHAPE. THE PHYSICIAN DECIDED TO CLOSE AS MUCH OF THE LAA AS POSSIBLE. IT WAS CHALLENGING TO DELIVER THE LARIAT DEVICE. AFTER SEVERAL ATTEMPTS IT WAS DECIDED THAT THE CASE SHOULD BE ABORTED. UPON REMOVING THE INTRODUCER SHEATH (SOFTIP), BLOOD BEGAN TO EXIT THE SOFTIP INDICATING AN EFFUSION OCCURRED. AUTO TRANSFUSION WAS PERFORMED. THE PHYSICIAN ELECTED TO SEND THE PATIENT TO SURGERY TO MANAGE THE EFFUSION. THE SURGEON INDICATED THAT PERFORATION OF THE RIGHT VENTRICLE OCCURRED. IT WAS HYPOTHESIZED THAT THE MULTIPLE ATTEMPTS TO INTRODUCE THE LARIAT MAY HAVE CONTRIBUTED TO THE SOFTIP PERFORATING THE RV AND THAT THE EFFUSION WAS NOT SEEN IMMEDIATELY SINCE THE SOFTIP WAS IN PLACE. PER THE SURGEON, THE PATIENT WAS STABLE DURING THE EVENING HOWEVER THE PATIENT'S HEALTH DETERIORATED AND THE NEXT DAY THE PATIENT EXPIRED. THE PHYSICIAN MENTIONED THAT THE PATIENT HAD "LITTLE RESERVE" AND THAT THE SURGERY COMPROMISED THEIR STABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613765 SOFTIP INTRODUCER SHEATH/CANNULA GAT SENTREHEART, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R