BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIFIX

    MDR report key: 7405906 · Received April 8, 2018

    Report

    Report Number
    3013436960-2018-00001
    Event Type
    Injury
    Date Received
    April 8, 2018
    Date of Event
    March 14, 2018
    Report Date
    April 8, 2018
    Manufacturer
    ARRINEX, INC
    Product Code
    GEH
    PMA / PMN Number
    K162608
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE OF EPISTAXIS UNKNOWN. PHYSICIAN PERFORMING EMBOLIZATION WAS UNABLE TO LOCATE SOURCE OF THE BLEEDING, AND ENDOSCOPIC EVALUATION AT DAY 7 AND POST-EMBOLIZATION DID NOT SHOW SOURCE OF BLEEDING OR TISSUE DAMAGE. DEVICE WAS DISCARDED AFTER CASE AS THERE WAS NO ISSUE WITH DEVICE DURING TREATMENT.

    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 VISUALIZATIONS IN THE DOCTOR'S OFFICE ON (B)(6) 2018. PATIENT RETURNED FOR 7 DAY FOLLOW UP AND ENDOSCOPY SHOWED TREATMENT AREA TO BE "PERFECTLY NORMAL" AND "COMPLETELY HEALED" PER PHYSICIAN. PATIENT WAS USING SALINE SPRAY POST-TREATMENT AND AZELASTINE SPRAY FOR EXCESSIVE DRIPPING. PATIENT REPORTED THAT A CLOT WAS NOTICED OUT OF THE LEFT SIDE OF HIS NOSE "A FEW DAYS" POST-TREATMENT. PATIENT ALSO REPORTED THAT TWO DAYS PRIOR TO THE EPISTAXIS HE CUT HIS LEFT NOSTRIL WHILE GROOMING. PATIENT PRESENTED IN ER ON (B)(6) 2018 WITH SEVERE EPISTAXIS ON THE LEFT SIDE. ER PERSONNEL PHONED TREATING PHYSICIAN TO INFORM HIM AND PHYSICIAN RECOMMENDED A EMBOLIZATION OF THE SPA, WHICH IS HIS PREFERENCE IN SEVERE EPISTAXIS CASES RATHER THAN PACKING. HOSPITAL NEUROLOGIST PERFORMED EMBOLIZATION BUT WAS UNABLE TO IDENTIFY WHERE THE BLEEDING WAS COMING FROM AND DID NOT SEE ANY BLEEDING FROM THE SPA. PATIENT WAS PACKED AND SENT HOME. PACKING WAS PULLED ON (B)(6) 2018 AND THERE WAS NO ACTIVE BLEEDING. PATIENT WAS SEEN IN-OFFICE BY TREATING PHYSICIAN ON (B)(6) 2018 AND NO BLEEDING WAS NOTED AND NO EVIDENCE OF THE SOURCE OF THE BLEEDING WAS IDENTIFIED. PHYSICIAN NOTED MUCASY FILM IN THE MIDDLE MEATUS BUT NO BLEEDING. PATIENT WAS STABLE AND DOING WELL. PATIENT WAS A MALE, UNKNOWN AGE WITH NO HISTORY OF NOSEBLEEDS, NOT ON BLOOD THINNERS, NOT A SMOKER. PATIENT DOES HAVE HISTORY OF HYPERTENSION. PATIENT HAD PREVIOUSLY HAD SURGERY FOR A DEVIATED SEPTUM SEVERAL YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248587 CLARIFIX CRYOABLATION DEVICE GEH ARRINEX, INC CFX-0001 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention