BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIFIX DEVICE

    MDR report key: 6819086 · Received August 24, 2017

    Report

    Report Number
    3013436960-2017-00002
    Event Type
    Injury
    Date Received
    August 24, 2017
    Date of Event
    July 28, 2017
    Report Date
    August 24, 2017
    Manufacturer
    ARRINEX, INC
    Product Code
    GEH
    PMA / PMN Number
    K162608
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE DETERMINED TO BE NON-STANDARD TREATMENT OF CARE POST-PROCEDURE WITH REMOVAL OF RETAINED PLEDGET 19 DAYS POST-PROCEDURE CAUSING TISSUE DAMAGE LIKELY RESULTING IN NOSEBLEED. INCIDENT OCCURED AS PART OF A POST-MARKET CLINICAL STUDY AND RECORDED AS A SERIOUS ADVERSE EVENT WHICH WAS NOT DEVICE RELATED. DEVICE WAS DISCARDED AFTER CASE AS THERE WAS NO ISSUE WITH DEVICE DURING ITS USE. LOT # WAS OBTAINED AND LOT HISTORY REVIEW SHOWED NOTHING UNUSUAL ABOUT THIS MANUFACTURING BUILD. DEVICES WERE SHOWN TO MEET SPECIFICATION AND UNDERWENT ALL TESTING REQUIRED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM THE TREATING PHYSICIAN IN ORDER TO COMPLETE THE COMPLAINT INVESTIGATION. PATIENT RECEIVED BILATERAL CRYOTHERAPY IN THE NASAL PASSAGEWAY UNDER ENDOSCOPIC VISUALIZATION IN THE DOCTOR'S OFFICE ON (B)(6) 2017. THIS WAS PART OF A POST-MARKET CLINICAL STUDY. PROCEDURE WAS SUCCESSFULLY COMPLETED AS EXPECTED. DEVICE PERFORMED AS EXPECTED. IMMEDIATELY FOLLOWING THE COMPLETION OF THE PROCEDURE, THE PATIENT'S PAIN CONTINUED AND BEGAN TO INCREASE OVER THIRTY MINUTES. PHYSICIAN ELECTED TO PLACE A TETRACAINE-SOAKED NASAL PLEDGET IN THE LEFT MIDDLE MEATUS. THE PATIENT WAS MONITORED FOR APPROXIMATELY 50 MINUTES AFTER THE COMPLETION OF THE CRYOTHERAPY PROCEDURE AT WHICH TIME SHE REPORTED SHE WAS DOING BETTER AND WANTED TO GET HOME TO TAKE PAIN MEDICATION AND REST. PHYSICIAN FAILED TO REMEMBER TO REMOVE PLEDGET FROM NOSE AT THIS TIME. ON (B)(6) 2017: PATIENT WAS CONTACTED VIA PHONE AND REPORTED PAIN MEDICATION USAGE BUT NO ADVERSE EVENTS. THIS WAS A SCHEDULED CALL PER THE CLINICAL STUDY PROTOCOL. ON (B)(6) 2017: PATIENT HAD IN-OFFICE FOLLOW UP (PART OF CLINICAL STUDY PROTOCOL). AN ADVERSE EVENT WAS REPORTED AS PATIENT CONTINUED TO HAVE CHEEK PAIN SINCE DAY OF PROCEDURE. PATIENT REPORTED CONTINUING PAIN MEDICATION AS NEEDED FOR PAIN. ALSO COMPLAINED OF CONGESTION. LIMITED ENDOSCOPY REVEALED NO BLEEDING, NO PUSS, TURBINATES WERE SWOLLEN. NO ACTION TAKEN. ON (B)(6) 2017: PATIENT HAS IN-OFFICE PHYSICIAN VISIT (UNPLANNED FROM CLINICAL STUDY PROTOCOL). PHYSICIAN REMOVED RETAINED PLEDGET. LEFT SIDE ENDOSCOPY WAS PERFORMED. LIGHT MUCOUS WAS NOTED WITH NO BLEEDING FROM LEFT MIDDLE MEATUS. ON (B)(6) 2017: PATIENT WENT TO EMERGENCY ROOM FOR SEVERE NOSEBLEED. RAPID RHINO PACK WAS USED TO PACK NOSE. PATIENT RETURNED HOME. ON (B)(6) 2017: PATIENT RETURNED FOR IN-OFFICE PHYSICIAN VISIT (UNPLANNED FROM CLINICAL STUDY PROTOCOL). NASAL PACKING WAS REMOVED AND LEFT SIDE BLEEDING ENSUED. NEW RAPID RHINO INSERTED AND PATIENT WAS MONITORED UNTIL STABLE AND THEN SENT TO EMERGENCY ROOM FOR FURTHER TREATMENT. PATIENT WAS ADMITTED TO HOSPITAL AND UNDERWENT CAUTERY FOR ARTERIOLAR BLEED UNDER GENERAL ANESTHESIA. IN PHYSICIAN'S OPINION THIS WAS NECESSARY AS NASAL PACKING WAS NOT ALLEVIATING THE BLEEDING. CESSATION OF THE BLEED WAS IMMEDIATELY SUCCESSFUL WHEN SUCTION BOVIE ELECTROCAUTERY WAS EMPLOYED. ON (B)(6) 2017: PATIENT WAS DISCHARGED - EPISTAXIS WAS STABILIZED. ON (B)(6) 2017: PATIENT HAS IN-OFFICE PHYSICIAN VISIT (UNPLANNED FROM CLINICAL STUDY PROTOCOL). LEFT RAPID RHINO CAREFULLY DEFLATED AND REMOVED FROM NOSE. MIDDLE MEATUS WITH GEL FOAM, NO FRESH OR OLD BLOOD NOTED. PACKING WAS NOT REMOVED. PHYSICIAN ADVISED PATIENT ON NOSEBLEED PRECAUTIONS AND SCHEDULED FOLLOW-UP VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597894 CLARIFIX DEVICE CRYOABLATION DEVICE GEH ARRINEX, INC CFX-0001 17050501

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R