BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINDRWIRZ GUIDE WIRE SYSTEM

    MDR report key: 2580839 · Received May 16, 2012

    Report

    Report Number
    3005802238-2012-00003
    Event Type
    Injury
    Date Received
    May 16, 2012
    Date of Event
    April 24, 2012
    Report Date
    May 16, 2012
    Manufacturer
    SENTREHEART, INC.
    Product Code
    DQX
    PMA / PMN Number
    K080364
    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 LOCATION OF PERICARDIAL ACCESS AND THE ORIENTATION OF THE LAA REQUIRED ADD'L MANIPULATION OF THE LARIAT WHILE TRYING TO CAPTURE THE LAA FOR LIGATION. THE FINDRWIRZ MOST LIKELY PERFORATED THE LAA AT SOME POINT DURING THIS ADD'L MANIPULATION. PERICARDIOCENTESIS WAS PERFORMED AND THE PT REMAINED STABLE. THE PROCEDURE CONTINUED AND SUCCESSFUL LAA LIGATION WITH THE LARIAT WAS PERFORMED, ELIMINATING THE BLEEDING. THE PT THEN RECOVERED NORMALLY WITH NO FURTHER SEQUELAE. POTENTIAL VESSEL DAMAGE IS A KNOWN COMPLICATION LISTED IN THE IFU. THE DEVICE WAS NOT RETURNED FOR EVAL AND THERE IS NOT 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

    IT WAS REPORTED THAT A .025" FINDRWIRZ PERFORATED THE LEFT ATRIAL APPENDAGE, RESULTING IN BLEEDING. PERICARDIOCENTESIS WAS PERFORMED WHILE THE LARIAT SUTURE DELIVERY DEVICE WAS ADVANCED OVER THE LAA. THE BLEEDING RESOLVED AFTER SUCCESSFUL LAA LIGATION. THE PT RECOVERED AND WAS DISCHARGED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINDRWIRZ GUIDE WIRE SYSTEM GUIDE WIRE DQX SENTREHEART, INC. NA 71110063

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention LARIAT SUTURE DELIVERY DEVICE| ENDOCATH OCCLUSION BALLOON