BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTIP GUIDE CANNULA

    MDR report key: 3682757 · Received February 20, 2014

    Report

    Report Number
    3005802238-2014-00002
    Event Type
    Injury
    Date Received
    February 20, 2014
    Date of Event
    January 21, 2014
    Report Date
    February 18, 2014
    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

    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 PATIENT WAS UNDERGOING LEFT ATRIAL APPENDAGE LIGATION WITH THE LARIAT SUTURE DELIVERY DEVICE. THE DOCTOR ACHIEVED PERICARDIAL ACCESS AND PLACED THE SOFTIP GUIDE CANNULA WITHOUT INCIDENT. THE DOCTOR SUCCESSFULLY CAPTURED THE LAA WITH THE LARIAT. REMOVAL OF THE LARIAT FROM THE LAA REQUIRED MULTIPLE ATTEMPTS. UPON REMOVAL OF THE SOFTIP SHEATH, BLEEDING OCCURRED. THE BLEEDING REQUIRED SURGERY TO CORRECT. IT WAS THEN CONCLUDED BY THE PHYSICIAN THAT THE SHEATH HAD "KNICKED" THE RV. SURGICAL INTERVENTION SUCCESSFULLY REPAIRED THE RV AND THE PATIENT WAS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106984 SOFTIP GUIDE CANNULA GUIDE CANNULA GAT SENTREHEART INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention FINDRWIRZ GUIDE WIRE SYSTEM| LARIAT SUTURE DELIVERY DEVICE