BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIFIX DEVICE

    MDR report key: 6559408 · Received May 10, 2017

    Report

    Report Number
    3013436960-2017-00001
    Event Type
    Injury
    Date Received
    May 10, 2017
    Date of Event
    March 29, 2017
    Report Date
    April 27, 2017
    Manufacturer
    ARRINEX, INC.
    Product Code
    GEH
    PMA / PMN Number
    K162608
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RETURNED. THE DEVICE WAS DISCARDED AFTER THE CASE AS THERE WAS NO ISSUE WITH THE DEVICE DURING ITS USE. THE LOT INFORMATION ASSOCIATED WITH THE DEVICE COULD NOT BE DETERMINED. HOWEVER, BASED ON THE INFORMATION COLLECTED, THERE IS NO INDICATION THAT THE DEVICE FAILED TO MEET SPECIFICATION.

    Description of Event or Problem · 1

    THE INFORMATION WAS OBTAINED FROM DR. (B)(6), WHO PERFORMED CRYOTHERAPY ON THE PATIENT, TO SUPPLEMENT THE COMPLAINT INVESTIGATION. THIS WAS A BILATERAL CRYOTHERAPY USING THE CLARIFIX DEVICE COMBINED WITH A RESECTION OF A CONCHA BULLOSA ON THE PATIENT'S LEFT NASAL PASSAGEWAY. THE PATIENT WAS A (B)(6) YEAR-OLD FEMALE WITH A HISTORY OF HYPERTENSION. THE PROCEDURE WAS PERFORMED UNDER ENDOSCOPIC VISUALIZATION IN THE DOCTOR'S OFFICE WHILE PATIENT WAS UNDER MILD SEDATION ON (B)(6) 2017. THE CASE WENT SMOOTHLY AS PLANNED. THERE WAS NO EXCESSIVE BLEEDING OR OTHER COMPLICATIONS AND THE PATIENT WAS RELEASED TO GO HOME WITHOUT ANY CONCERNS. THE PATIENT DID HAVE FISH OIL AND KRILL OIL LISTED IN HER MEDICATION LIST, BUT WAS OFF OF THOSE FOR 10 DAYS PRE OP. ON (B)(6) 2017 (27 DAYS POST TREATMENT), THE PATIENT WAS SEEN IN THE OFFICE BY DR. (B)(6) FOR ROUTINE POST TREATMENT EXAM. PATIENT INDICATED SHE "WAS NOT FEELING WELL." A NASAL ENDOSCOPY WAS ATTEMPTED BUT EVEN AFTER SEVERAL BILATERAL SPRAYS OF OXYMETAZOLINE (A VASOCONSTRICTOR) WAS APPLIED, THE TREATMENT SITES COULD NOT BE VISUALIZED ON EITHER SIDE. FURTHER QUESTIONING REVEALED THAT PATIENT HAD NOT TAKEN HER ORAL ANTIHISTAMINES OR NASAL STEROIDS AS INSTRUCTED. ACCORDING TO DR. (B)(6), THIS IS SIGNIFICANT BECAUSE THE (B)(6) AREA HAD ITS WORST OAK SEASON IN 20 YEARS THIS YEAR. THE HEIGHT OF THE SEASON WAS DURING (B)(6). SHE WAS ATTEMPTING TO USE SALINE, BUT WITH LIMITED SUCCESS DUE TO THE SWELLING IN HER NOSE. DR. (B)(6) FELT THE SWELLING WAS DUE TO ALLERGIES BECAUSE IT WAS DIFFUSE AND INVOLVED HER ENTIRE NASAL MUCOSA. THE OTHER OPTION FOR THIS TYPE OF SWELLING WAS INFECTION, BUT THERE WAS NO EVIDENCE OF PURULENT DRAINAGE, WHICH WOULD HAVE INDICATED INFECTION. PHYSICIAN INSTRUCTED PATIENT TO START BACK ON ANTIHISTAMINES AND NASAL STEROID SPRAYS TO REDUCE THE SWELLING IN HER NOSE AS WELL AS OTHER NASAL ALLERGY SYMPTOMS. ON (B)(6) 2017, PATIENT WENT TO THE EMERGENCY ROOM WITH A SEVERE NOSEBLEED THAT WAS STOPPED BY AN ER PHYSICIAN USING SPRAYS OF OXYMETAZOLINE. ON (B)(6) 2017, PATIENT RETURNED TO SEE DR. (B)(6). PATIENT'S BLOOD PRESSURE ON THAT DAY WAS 123/57 WHICH WAS ABOUT NORMAL FOR HER. ENDOSCOPIC ASSESSMENT SHOWED RHINITIS HAD CONSIDERABLY IMPROVED BUT THERE WAS A BLOOD CLOT PRESENT IN PATIENT'S RIGHT OSTEOMEATAL COMPLEX. SHE WAS ENCOURAGED TO IRRIGATE FREQUENTLY WITH SALINE TO HELP THIS AREA HEAL. ON (B)(6) 2017, PATIENT PRESENTED AT THE EMERGENCY ROOM WITH A SEVERE NOSEBLEED. BOTH SIDES OF THE PATIENT'S NASAL PASSAGEWAYS WERE PACKED BY THE ER PHYSICIAN. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND THAT EVENING, DR. (B)(6) TOOK THE PATIENT TO THE OR AND REMOVED THE PACKING. AN ISOLATED BLEEDING SITE OF THE RIGHT POSTERO-LATERAL OMC WAS IDENTIFIED. IT WAS CAUTERIZED WITH BIPOLAR FORCEPS AND THE NOSE WAS REPACKED WITH A DOYLE SPLINT AND MEROCEL THAT WAS PLACED IN THE OMC. THE LEFT SIDE WAS INSPECTED AND WAS COMPLETELY HEALED. THE PATIENT WAS SENT BACK TO THE FLOOR POSTOPERATIVELY. AFTER THE PROCEDURE DR. (B)(6) DISCUSSED WITH THE HUSBAND THAT THE CAUTERIZATION LIKELY SOLVED THE PROBLEM. THE HUSBAND WAS QUITE ANXIOUS THAT THE PATIENT MIGHT BLEED AGAIN. DR. (B)(6) OFFERED TO ARRANGE AN EMBOLIZATION OF THE RIGHT SPHENOPALATINE ARTERY FOR THE NEXT DAY. AS A PRECAUTIONARY MEASURE, ON (B)(6) 2017, THE PATIENT UNDERWENT AN EMBOLIZATION OF THE SPHENOPALATINE ARTERY (SPA) AND SPENT TWO NIGHTS IN THE HOSPITAL AFTER THAT. THE PATIENT RECEIVED 3 UNITS OF BLOOD DUE TO HER LOW HEMOGLOBIN LEVEL AND WAS DISCHARGED ON (B)(6) 2017. SHE WAS DISCHARGED IN GOOD CONDITION. SHE WAS SEEN IN THE OFFICE ON (B)(6) 2017. SHE WAS FEELING WELL. HER EXAM SHOWED SOME EDEMA AND CRUSTING OF THE CAUTERY SITE. NO ADDITIONAL BLEEDING HAD OCCURRED. SHE WAS INSTRUCTED THAT A WHOLESOME DIET WOULD HELP HER RESTORE ANY RESIDUAL ANEMIA AND NO PLANS TO RECHECK HER HEMOGLOBIN WERE NECESSARY IF SHE DID NOT BLEED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339172 CLARIFIX DEVICE CYROABLATION DEVICE GEH ARRINEX, INC. CFX-0001 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R CONCHA BULLOSA RESECTION