BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTIP GUIDE CANNULA

    MDR report key: 2960267 · Received February 8, 2013

    Report

    Report Number
    3005802238-2013-00001
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 8, 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 PHYSICIAN HAD PLACED A BEND IN THE .035 FINDERWIRE THAT WAS PLACED THROUGH THE SOFTIP PRIOR TO INTRODUCING THE LARIAT. SEVERAL ATTEMPTS WERE MADE TO CONNECT THE .035 FINDRWIRE TO THE .025 FINDRWIRE THAT HAD BEEN PLACED INSIDE THE LAA. THE PHYSICIAN REMOVED THE .035 FINDRWIRE FOR THE PURPOSE OF REMOVING THE BEND AND THEN REINSERTED, OBSERVING THE PVC SHORTLY THEREAFTER. FOLLOWING THE SUCCESSFUL SURGICAL REPAIR, THE PHYSICIAN NOTED THAT IT APPEARED THE SOFTIP ENTERED THE RV TOWARD THE APEX AND WAS PERPENDICULAR TO THE HEART. THE INJURY WAS LARGER THAN THE SHEATH'S DIAMETER REPRESENTING SOME LACERATION PRIOR TO PERFORATION. HE SPECULATED THE BACK AND FORTH MANIPULATION OF THE SHEATH COMBINED WITH ITS INFERIOR POSITION TO THE APEX MAY HAVE LED TO DIRECT PRESSURE ON RV. 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 PT 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 REQUIRED MULTIPLE ATTEMPTS TO ADVANCE THE FINDERWIRE PRIOR TO INTRODUCING THE LARIAT. DURING THIS TIME, IT WAS OBSERVED THAT THE SOFTIP HAD MOVED BACK AND FORTH FROM ITS ORIGINAL LOCATION. PREVENTRICULAR CONTRACTIONS (PVC) WERE NOTED ON THE EKG AND THE DISTAL TIP OF THE SOFTIP WAS THEN VISUALIZED IN THE RIGHT VENTRICLE. IT WAS THEN CONCLUDED THAT THE SHEATH HAD PERFORATED THE RV. HEMODYNAMIC MANAGEMENT WAS IMMEDIATELY IMPLEMENTED AND PT WAS SENT TO SURGERY. THE PT HAD SUCCESSFUL OFF PUMP REPAIR OF THE RV AND THE LAA WAS SIMULTANEOUSLY SURGICALLY CLIPPED. THE PT WAS REPORTED TO BE RECOVERING NORMALLY AND WAS EXPECTED TO BE DISCHARGED WITHIN A FEW DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54248 SOFTIP GUIDE CANNULA GUIDE CANNULA GAT SENTREHEART INC. NA 70412009

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention LARIAT SUTURE DELIVERY DEVICE| FINDRWIRZ GUIDE WIRE SYSTEM