BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINDRWIRZ GUIDE WIRE SYSTEM

    MDR report key: 3133398 · Received May 24, 2013

    Report

    Report Number
    3005802238-2013-00006
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 24, 2013
    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

    ADDITIONAL INFORMATION WAS PROVIDED BY THE SENTREHEART REPRESENTATIVE WHO ATTENDED THE CASE. THE PATIENT ANATOMY REQUIRED ADDITIONAL MANIPULATION OF THE LARIAT WHILE TRYING TO CAPTURE THE LAA FOR LIGATION. FOLLOWING SUCCESSFUL PLACEMENT OF THE FINDRWIRZ IN THE LAA, SEVERAL ATTEMPTS WERE MADE TO CAPTURE THE LAA WITH THE LARIAT SUTURE DELIVERY DEVICE. THE FINDRWIRZ MOST LIKELY PERFORATED THE LAA AT SOME POINT DURING THIS ADDITIONAL MANIPULATION. PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT REMAINED STABLE. AFTER SOME TIME, THE PHYSICIAN DECIDED TO SEND THE PATIENT TO SURGERY WHERE A SUCCESSFUL SURGICAL LIGATION OF THE LAA WAS PERFORMED. THE PATIENT THEN RECOVERED NORMALLY WITH NO FURTHER SEQUELAE. POTENTIAL VESSEL DAMAGE IS A KNOWN COMPLICATION LISTED IN THE IFU. 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

    IT WAS REPORTED THAT A 0.025" FINDRWIRE PERFORATED THE LEFT ATRIAL APPENDAGE, RESULTING IN BLEEDING. PERICARDIOCENTESIS WAS PERFORMED WHILE THE PHYSICIAN ATTEMPTED TO ADVANCE A LARIAT SUTURE DELIVERY DEVICE OVER THE LAA. THE PHYSICIAN WAS UNABLE TO SUCCESSFULLY COMPLETE THE LIGATION AND THE PATIENT WAS SENT TO SURGERY WHERE A SUCCESSFUL SURGICAL LIGATION OF THE LAA WAS PERFORMED. THE PATIENT RECOVERED AND WAS DISCHARGED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231859 FINDRWIRZ GUIDE WIRE SYSTEM GUIDE WIRE DQX SENTREHEART INC. NA 71212077

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention