BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINDRWIRZ GUIDE WIRE SYSTEM

    MDR report key: 2538960 · Received April 11, 2012

    Report

    Report Number
    3005802238-2012-00002
    Event Type
    Injury
    Date Received
    April 11, 2012
    Date of Event
    March 12, 2012
    Report Date
    April 10, 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

    ADDITIONAL INFORMATION WAS PROVIDED BY THE SENTREHEART REPRESENTATIVE WHO ATTENDED THE CASE. THE PT HAD AN ANTERIOR ORIENTED LAA. THIS COMBINED WITH THE LOCATION OF PERICARDIAL ACCESS RESULTED IN ADDITIONAL MANIPULATION OF THE LARIAT WHILE TRYING TO CAPTURE THE LAA FOR LIGATION. THE FINDRWIRZ PERFORATED THE LAA AT SOME POINT DURING THIS ADDITIONAL MANIPULATION. ALL DEVICES WERE REMOVED FROM THE PT WHILE PERICARDIOCENTESIS WAS PERFORMED AND HEPARIN WAS REVERSED. TEE CONFIRMED BLEEDING RESOLVED AFTER 90 MINUTES. THE PT THEN RECOVERED NORMALLY WITH NO FURTHER SEQUELAE. POTENTIAL VESSEL DAMAGE IS A KNOWN 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

    IT WAS REPORTED THAT A FINDRWIRZ PERFORATED THE LEFT ATRIAL APPENDAGE, RESULTING IN BLEEDING. PERICARDIOCENTESIS WAS PERFORMED WHILE HEPARIN WAS REVERSED. 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 77 YR Required Intervention ENDOCATH OCCLUSION BALLOON| LARIAT SUTURE DELIVERY DEVICE