BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINDRWIRE GUIDE WIRE SYSTEM

    MDR report key: 2678547 · Received June 18, 2012

    Report

    Report Number
    3005802238-2012-00004
    Event Type
    Injury
    Date Received
    June 18, 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

    ADDITIONAL INFO WAS PROVIDED BY THE SENTREHEART REP WHO ATTENDED THE CASE: THE INITIAL PLACEMENT OF THE FINDRWIRZ REQUIRED ADDITIONAL MANIPULATION DUE TO THE HIGH-FOSSA LOCATION OF THE TRANSSEPTAL PUNCTURE AND BECAUSE THE ECHOCARDIOGRAPHER WAS HAVING DIFFICULTY OBTAINING GOOD VISUALIZATION ON TEE. FOLLOWING SUCCESSFUL PLACEMENT OF THE FINDRWIRZ IN THE LAA, SEVERAL ATTEMPTS WERE MADE TO CAPTURE THE LAA WITH THE LARIAT SUTURE DELIVERY DEVICE, DESPITE CONTINUED DIFFICULTY OBTAINING GOOD VISUALIZATION ON TEE. THE FINDRWIRZ MOST LIKELY PERFORATED THE LAA AT SOME POINT DURING THIS ADDITIONAL MANIPULATION. PERICARDIOCENTESIS WAS PERFORMED AND THE PT REMAINED STABLE. THE PROCEDURE CONTINUED AND THE PHYSICIAN SUCCESSFULLY CAPTURED THE LAA WITH THE LARIAT IN PREPARATION FOR LIGATION, WHICH WAS OBSERVED TO STOP THE BLEEDING. HOWEVER, BEFORE THE SUTURE COULD BE DEPLOYED FROM THE LARIAT, THE LARIAT SLIPPED OFF THE LAA. THE PHYSICIAN THEN DECIDED TO SEND THE PT TO SURGERY WHERE A SUCCESSFUL SURGICAL LIGATION OF THE LAA WAS PERFORMED. IN A FOLLOW UP COMMUNICATION WITH THE PHYSICIAN ON (B)(6) 2012, HE REPORTED THE PT WAS DISCHARGED ON (B)(6) 2012 AND WAS RECOVERING NORMALLY. POTENTIAL VESSEL DAMAGE IS A KNOWN COMPLICATION LISTED IN THE IFU. THE DEVICE WASN'T RETURNED FOR EVALUATION. 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 .025" FINDRWIRZ 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 PT WAS SENT TO SURGERY WHERE A SUCCESSFUL SURGICAL LIGATION OF THE LAA WAS PERFORMED. THE PT WAS REPORTED STABLE 24 HOURS POST PROCEDURE AND WAS EXPECTED TO BE DISCHARGED IN A FEW DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINDRWIRE GUIDE WIRE SYSTEM GUIDE WIRE DQX SENTREHEART INC. NA 71110028

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention ENDOCATH OCCLUSION BALLOON| LARIAT SUTURE DELIVERY DEVICE