BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIFIX

    MDR report key: 7860561 · Received September 10, 2018

    Report

    Report Number
    3013436960-2018-00002
    Event Type
    Injury
    Date Received
    September 10, 2018
    Date of Event
    June 30, 2018
    Report Date
    September 6, 2018
    Manufacturer
    ARRINEX, INC
    Product Code
    GEH
    PMA / PMN Number
    K162608
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HAD PREEXISTING HISTORY OF FREQUENT POSTERIOR NOSEBLEEDS AND WAS TAKING BLOOD THINNERS. IT IS UNKNOWN IF TREATMENT WITH CRYOABLATION DEVICE AGGRAVATED THIS CONDITION OR NOT. PATIENT RECOVERED AFTER CAUTERIZATION 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. PATIENT FOLLOWED POST-TREATMENT INSTRUCTIONS FOR SALINE SPRAY. PATIENT DID NOT FOLLOW PHYSICIAN'S RECOMMENDATION TO HOLD OFF ON TAKING ANTICOAGULANT FOR 5 DAYS AFTER PROCEDURE. PATIENT HAD BRIEF BLEED WHICH STOPPED SPONTANEOUSLY ON (B)(6) 2018. PATIENT PRESENTED IN ER ON (B)(6) 2018 WITH SEVERE EPISTAXIS. NOSE PACKED AND TRANSFUSION GIVEN. TAKE TO OPERATING ROOM (OR) (B)(6) 2018 FOR CAUTERY ON BOTH SIDES. ANTICOAGULANT BRILINTA STOPPED AT THAT TIME AND PATIENT HAS HAD NO FURTHER BLEEDING. PATIENT SEEN BY TREATING PHYSICIAN ON (B)(6) 2018 AND DOING WELL WITH RESOLUTION OF SYMPTOMS AND NO BLEEDING. AFTER PRESENTING WITH EPISTAXIS,PATIENT DISCLOSED HE HAD A PRE-EXISTING CONDITION: 6 MONTHS HISTORY OF RECURRING HEMOPTYSIS (COUGHING BLOOD) EVALUATED BY PULMONOLOGIST WITH NEGATIVE BRONCHOSCOPY. PHYSICIAN FEELS THAT IN RETROSPECT THIS WAS LIKELY RECURRING POSTERIOR NASAL BLEEDING, BUT NO EVIDENCE OF BLEEDING SOURCE ON HIS INITIAL EVALUATION WITH THE TREATING PHYSICIAN. PHYSICIAN BELIEVES PATIENT MAY ALSO BE TAKING HYPERTENSIVE DRUGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700298 CLARIFIX CRYOABLATION DEVICE GEH ARRINEX, INC CFX-0001 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention