BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIFIX

    MDR report key: 9240428 · Received October 25, 2019

    Report

    Report Number
    3015132143-2019-00002
    Event Type
    Injury
    Date Received
    October 25, 2019
    Date of Event
    September 26, 2019
    Report Date
    October 25, 2019
    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

    PATIENT REPORTED NOSEBLEED THE NIGHT BEFORE THE CRYOABLATION TREATMENT (UNKNOWN SOURCE AND SEVERITY). PATIENT WAS ALSO ON BLOOD THINNERS AND MEDICATION FOR HYPERTENSION, ALTHOUGH IT IS UNKNOWN WHAT PATIENT'S BLOOD PRESSURE WAS AT TIME OF TREATMENT. IT IS UNKNOWN IF TREATMENT WITH CLARIFIX CAUSED THE NOSEBLEED OR AGGRAVATED A PRE-EXISTING CONDITION. PATIENT RECOVERED AFTER CAUTERIZATION. AT THE TIME OF THIS REPORT, NO FURTHER PATIENT INJURY OR NEGATIVE HEALTH RELATED OUTCOMES HAVE BEEN REPORTED. THE DEVICE WAS DISCARDED AFTER THE PROCEDURE AND THE SERIAL NUMBER WAS NOT PROVIDE/UNKNOWN. THEREFORE, NO INVESTIGATION OF THE DEVICE WAS COMPLETED.

    Description of Event or Problem · 1

    MALE PATIENT RECEIVED BILATERAL CRYOTHERAPY IN THE NASAL PASSAGEWAY UNDER ENDOSCOPIC VISUALIZATION IN THE DOCTOR'S OFFICE ON (B)(6) 2019. TREATMENT PROTOCOL FOLLOWED IFU (30 SECOND FREEZE, SINGLE FREE FOLLOWED BY 45 SECOND THAW), LEFT SIDE TREATED FIRST FOLLOWED BY RIGHT SIDE. NO ISSUES WITH TREATMENT. IMMEDIATELY AFTER TREATING THE RIGHT SIDE, PATIENT BEGAN BLEEDING FROM LEFT SIDE. BLEEDING WAS NOT SEVERE AT FIRST BUT PERSISTENT. PHYSICIAN TRIED PACKING WITH SURGICEL AND OTHER PACKING MATERIAL BUT BLEEDING DID NOT STOP. BLEEDING CONTINUED APPROXIMATELY 4 HOURS WHEN PHYSICIAN CALLED 911 AND PATIENT WAS TAKEN TO ER. PATIENT ADMITTED TO HOSPITAL AND DISCHARGED THE FOLLOWING DAY WITH PACKING. PATIENT RECEIVED BLOOD TRANSFUSION DURING HOSPITAL STAY. "SEVERAL WEEKS LATER" BLEEDING WAS CAUTERIZED IN OR. PHYSICIAN NOTED THAT BLEEDING WAS "ADJACENT TO SEPTUM." PATIENT SEEN FOR FOLLOWUP BY PHYSICIAN ON OCTOBER 21, 2019 AND REPORTED DOING FINE WITH NO BLEEDING FOR PAST 8 DAYS. PATIENT REPORTED HE HAD A NOSEBLEED THE NIGHT BEFORE RECEIVING CRYOTHERAPY TREATMENT. PATIENT TAKING ASPIRIN, ELIQUIS (BLOOD THINNERS), ATORVASTATIN (CHOLESTEROL) AND AMLODIPINE (HIGH BLOOD PRESSURE). PATIENT'S BLOOD PRESSURE AT TIME OF TREATMENT UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035370 CLARIFIX CRYOABLATION DEVICE GEH ARRINEX, INC CFX-0001 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention