BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIFIX

    MDR report key: 7982130 · Received October 18, 2018

    Report

    Report Number
    3013436960-2018-00003
    Event Type
    Injury
    Date Received
    October 18, 2018
    Date of Event
    July 16, 2018
    Report Date
    October 10, 2018
    Manufacturer
    ARRINEX, INC
    Product Code
    GEH
    PMA / PMN Number
    K162608
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HAD PREEXISTING HISTORY OF NOSEBLEEDS AND WAS BEING TREATED FOR HYPERTENSION AND DIABETES. IT IS UNKNOWN IF TREATMENT WITH CRYOABLATION DEVICE AGGRAVATED THIS CONDITION OR NOT. PATIENT RECOVERED AFTER EMBOLIZATION OF EPISTAXIS.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM THE TREATING PHYSICIAN IN ORDER TO COMPLETE THE COMPLAINT INVESTIGATION. MALE PATIENT RECEIVED BILATERAL CRYOTHERAPY IN THE NASAL PASSAGEWAY UNDER ENDOSCOPIC VISUALIZATION IN THE DOCTOR'S OFFICE ON (B)(6) 2018. ON (B)(6) 2018 PATIENT PRESENTED IN EMERGENCY ROOM WITH EPISTAXIS WHICH WAS CAUTERIZED AND PACKED IN THE ER WHICH RESOLVED ISSUE. PATIENT CONTINUED TO COMPLAIN OF SEVERE EPISTAXIS POST-ER VISIT; DR. (B)(6) SAW HIM IN THE OFFICE TWO DAYS LATER AND ENDOSCOPICALLY EVALUATED THE CLARIFIX TREATMENT SITE WHICH WAS OBSERVED TO BE HEALED: NO CRUSTING OR INFLAMMATION NOTED. PATIENT LATER RETURNED TO ER WITH POSTERIOR EPISTAXIS. PATIENT SEEN BY INTERVENTIONAL RADIOLOGIST WHO COULD NOT IDENTIFY SOURCE OF THE BLEEDING. SPHENOPALATINE ARTERY WAS EMBOLIZED BY INTERVENTIONAL RADIOLOGIST AT HOSPITAL. THIS RESOLVED EPISTAXIS. PATIENT HAD A HISTORY OF NOSE BLEEDS AND PREVIOUS NASAL SURGERY (SEPTOPLASTY (DATE UNKNOWN), NASAL VALVE REPAIR ((B)(6))). PATIENT WAS NOT OVERWEIGHT, BUT TAKING BLOOD PRESSURE MEDICATION (LISINOPRIL, CARDIZEM (DILTIAZEM)) AND DIABETES MEDICATION (METFORMIN). SOURCE OF EPISTAXIS UNDETERMINED. UNKNOWN IF RELATED TO CLARIFIX TREATMENT, BUT APPEARS UNLIKELY GIVEN THAT TREATMENT SITE WAS HEALED AND PATIENT HAD A HISTORY OF NOSEBLEEDS PRIOR TO TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822152 CLARIFIX CRYOABLATION DEVICE GEH ARRINEX, INC CFX-0001 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention