BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINDRWIRZ GUIDE WIRE SYSTEM

    MDR report key: 2459747 · Received February 8, 2012

    Report

    Report Number
    3005802238-2012-00001
    Event Type
    Injury
    Date Received
    February 8, 2012
    Date of Event
    January 9, 2012
    Report Date
    January 31, 2012
    Manufacturer
    SENTREHEART INC.
    Product Code
    DQX
    PMA / PMN Number
    K080364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WAS PROVIDED BY THE SENTREHEART REPRESENTATIVE WHO ATTENDED THE CASE. THE .025" FINDRWIRE WAS BEING USED WITH THE ENDOCATH BALLOON AND WAS ADVANCED TOO FAR INTO THE LAA CAUSING THE PERFORATION. AS PER NORMAL GUIDE WIRE TECHNIQUE, IT IS PREFERABLE TO HAVE A LENGTH OF GUIDE WIRE PROTRUDING DISTAL OF THE CATHETER. POTENTIAL VESSEL DAMAGE IS A KNOWN COMPLICATION LISTED IN THE IFU. THE DEVICE WAS NOT RETURNED FOR EVAL AND THERE IS NO EVIDENCE TO SUGGEST THERE WAS A DEVICE MALFUNCTION. A REVIEW OF MFG RECORDS CONFIRMED THE DEVICE MET SPECS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A .025" FINDRWIRE PERFORATED THE LEFT ATRIAL APPENDAGE, RESULTING IN BLEEDING. PERICARDIOCENTESIS WAS PERFORMED WHILE A 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 70211028

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention