BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIFIX

    MDR report key: 9372642 · Received November 25, 2019

    Report

    Report Number
    3015132143-2019-00003
    Event Type
    Injury
    Date Received
    November 25, 2019
    Date of Event
    November 4, 2019
    Report Date
    November 25, 2019
    Manufacturer
    ARRINEX, INC
    Product Code
    GEH
    PMA / PMN Number
    K162608
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT EXPERIENCED NOSE BLEED AFTER ADMINISTRATION OF ANESTHESIA, PRIOR TO THE CRYOABLATION TREATMENT. PATIENT HAD CEASED BLOOD THINNER MEDICATION 2-3 DAYS PRIOR TO SURGERY BUT WAS TAKING MEDICATION FOR HYPERTENSION, ALTHOUGH IT IS UNKNOWN WHAT PATIENT'S BLOOD PRESSURE WAS AT TIME OF TREATMENT. IT IS UNKNOWN IF TREATMENT WITH CLARIFIX AGGRAVATED THE PRE-EXISTING BLEEDING. PATIENT RECOVERED AFTER SPA LIGATION. 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 PROVIDED/UNKNOWN. THEREFORE, NO INVESTIGATION OF THE DEVICE WAS COMPLETED.

    Description of Event or Problem · 1

    FEMALE PATIENT RECEIVED BILATERAL CRYOTHERAPY IN THE NASAL PASSAGEWAY UNDER ENDOSCOPIC VISUALIZATION IN THE DOCTOR'S OFFICE ON (B)(6) 2019. PRIOR TO ADMINSTRATION OF CRYOTHERAPY, PHYSICIAN INJECTED ANESTHESIA INTO SPHENOPALATINE AREA AND A SLOW NOSE BLEED STARTED. PHYSICIAN ATTEMPTED TO STOP THE FLOW OF BLOOD BY APPLYING SILVER NITRATE, HOWEVER BLEEDING CONTINUED. CLARIFIX CRYOTHERAPY TREATMENT WAS PERFORMED EVEN THOUGH THERE WAS A SLIGHT BLEED. THE CRYOTHERAPY DEVICE WASN'T PLACED WHERE THE CUT FROM THE ANESTHESIA WAS. PHYSICIAN TRIED UNSUCCESSFULLY TO CAUTERIZE THE BLEED AND PACK THE NOSE WITH MIRACELL. PATIENT WAS ADMITTED TO THE ER FOR OBSERVATION. PATIENT RECEIVED SPHENOPALATINE ARTERY (SPA) LIGATION IN OR FOLLOWING ADMISSION TO HOSPITAL. PATIENT RECOVERED FROM SPA LIGATION WITH NO FURTHER ADVERSE CONSEQUENCES. PHYSICIAN INDICATED THAT PATIENT WAS ON BLOOD THINNERS PRIOR TO CRYOTHERAPY BUT STOPPED 2-3 DAYS PRIOR TO TREATMENT. PATIENT ALSO HAD HISTORY OF HIGH BLOOD PRESSURE AND WAS ON BLOOD PRESSURE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163712 CLARIFIX CRYOABLATION DEVICE GEH ARRINEX, INC CFX-0001 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S