BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIFIX

    MDR report key: 9046313 · Received September 13, 2019

    Report

    Report Number
    3015132143-2019-00001
    Event Type
    Injury
    Date Received
    September 13, 2019
    Date of Event
    August 17, 2019
    Report Date
    September 13, 2019
    Manufacturer
    ARRINEX, INC
    Product Code
    GEH
    PMA / PMN Number
    K162608
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICIAN STATED THAT HE BELIEVES PATIENT'S PRE-EXISTING HYPERTENSION MAY HAVE CONTRIBUTED TO EXCESSIVE BLEEDING. 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. UNKNOWN IF PATIENT FOLLOWED POST-TREATMENT INSTRUCTIONS. ON (B)(6) 2019, PATIENT PRESENTED WITH MAJOR EXSANGUINATING HEMORRHAGE FROM BOTH SIDES OF NASAL PASSAGEWAY AND HAD TO HAVE NASAL PACKING PLACED. ON (B)(6) 2019, PHYSICIAN REPORTED THAT PATIENT HAD INTERMITTENT BLEEDING WITH THE PACKING IN PLACE. PHYSICIAN INDICATED THAT HE WAS TAKING PATIENT TO OPERATING ROOM TO REMOVE THE NASAL PACK AND IF HE NOTED A DISTINCT BLEEDER, HE WOULD PERFORM ELECTROCAUTERIZE. HE FURTHER INDICATED HE WOULD HAVE A LOW THRESHOLD TO PERFORM SPHENOPALATINE ARTERY LIGATION. PHYSICIAN CONFIRMED ON 8/19/2019 THAT HE WAS UNABLE TO FIND AN ACTIVE BLEEDING SITE, BUT PERFORMED AN SPHENOPALATINE ARTERY LIGATION. ON 9/7/2019, PHYSICIAN PROVIDED ADDITIONAL INFORMATION THAT PATIENT HAD A HISTORY OF NOT PERFECTLY CONTROLLED BLOOD PRESSURE (E.G./ PATIENT WAS TAKING BLOOD PRESSURE MEDICINE BUT IT WAS APPARENT FROM DISCUSSION WITH ANESTHESIA THAT HE WAS SHOWING SIGNS OF BEING TOO HIGH ON THE FRONT END). PHYSICIAN BELIEVES A SCAB BROKE OFF AND BECAUSE OF HIS HIGH BLOOD PRESSURE HE CONTINUED TO BLEED FROM THE SPA AREA. DURING THE SURGERY HE COULD NOT SEE AN ACTIVE BLEEDING POINT THEREFORE HE FELT THE SPA LIGATION WAS NECESSARY IN ORDER TO ENSURE NO SUBSEQUENT BLEEDING. NO BLOOD TRANSFUSION REQUIRED. NO FURTHER PATIENT INJURY OR COMPLICATIONS. NO LONG-TERM CONSEQUENCES. PHYSICIAN STATED THAT HE BELIEVES PATIENT'S PRE-EXISTING HYPERTENSION MAY HAVE CONTRIBUTED TO EXCESSIVE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820012 CLARIFIX CRYOABLATION DEVICE GEH ARRINEX, INC CFX-0001 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention