BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM DELIVERY DEVICE KIT FOR BPH

    MDR report key: 6460486 · Received April 5, 2017

    Report

    Report Number
    3007795803-2017-00001
    Event Type
    Injury
    Date Received
    April 5, 2017
    Date of Event
    December 19, 2016
    Report Date
    February 20, 2017
    Manufacturer
    NXTHERA INC.
    Product Code
    KNS
    UDI-DI
    855357006010
    PMA / PMN Number
    K150786
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED IMMEDIATELY POST PROCEDURE AS IT PERFORMED AS EXPECTED. AFTER RECEIVING THE PATIENTS EMAIL RECOUNT NXTHERA CONDUCTED AN INTERNAL CLINICAL REVIEW OF THE REPORTED ADVERSE EVENT NOTING THE PATIENTS BASELINE PROSTATE SIZE WAS 184 GRAMS WHICH IS OUTSIDE OF THE APPROVED INDICATION FOR USE WHICH LIMITS THE PROSTATE SIZE TO 30-80 GRAMS. THE REZUM VAPOR THERAPY CAUTERIZES THE BLOOD VESSELS AROUND THE TREATMENT SITE AND IS USUALLY BLOODLESS. THEREFORE BLEEDING CANNOT BE FROM THE TREATMENT SITES BUT LIKELY FROM THE NON-TREATED TISSUES MOST LIKELY THE UROTHELIUM LINING ALTHOUGH THIS CANNOT BE CONFIRMED. NXTHERA OUTLINES THE APPROVED INDICATION FOR USE AS WELL AS THE ANTICIPATED ADVERSE EVENTS WITHIN THE INSTRUCTIONS FOR USE MANUAL WHICH IS AVAILABLE ON LINE AT HTTP://MAX1.REZUM.COM/WP-CONTENT/ UPLOADS/2016/07/3032-001_B_REZUM_IFU.PDF. ALL PHYSICIANS TRAINED ON THE REZUM PROCEDURE RECEIVE A COPY OF THE IFU AND THIS DOCUMENT IS ALSO AVAILABLE TO THE GENERAL PUBLIC.

    Description of Event or Problem · 1

    PATIENT RETURNED TO TREATING PHYSICIAN SIX DAYS POST RECEIVING THE REZUM PROCEDURE TO TREAT SYMPTOMATIC LUTS TO HAVE HIS INDWELLING FOLEY CATHETER REMOVED. AFTER A COUPLE OF HOURS OF RETURNING HOME THE PATIENT HAD HEMATURIA AND WAS IN PAIN. THE PATIENT'S WIFE THEN DROVE HIM BACK TO THE DOCTOR'S OFFICE WHERE HE TRIED TO RE-INSERT A FOLEY CATHETER. THE CATHETER INSERTION WAS UNSUCCESSFUL, FOLLOWED BY A FLEXIBLE ENDOSCOPE INSERTION WHICH WAS ALSO UNSUCCESSFUL. THE PATIENT COMPLAINED OF IMMENSE PAIN AND THE PATIENT WAS DRIVEN TO A LOCAL MEDICAL CENTER WHERE THE DOCTOR ADMITTED THE PATIENT FOR EMERGENCY BLOOD CLOT REMOVAL AND INSERTION OF A 26 FR 3-WAY FOLEY CATHETER. THE PATIENT UNDERWENT FOUR-DAYS OF CONTINUOUS FLUSHING OF BLOOD CLOTS AND PAIN CONTROL WITH NARCOTICS. THIS CATHETER WAS REMOVED ON (B)(6) 2017. ON (B)(6) 2017 AROUND 2300 THE PATIENT WAS RUSHED TO A LOCAL ER WITH URINARY BLEEDING. THE FOLLOWING DAY HE RETURNED TO THE ORIGINAL TREATING DOCTOR'S OFFICE WHERE A 24 FR 2 WAY FOLEY CATHETER WAS INSERTED. ON (B)(6) 2017 AROUND 0300 THE PATIENT WAS RUSHED A LOCAL ER WITH UNCONTROLLED URINARY BLEEDING WHERE > 1600 CC'S OF BLOOD CLOTS WERE REMOVED. AT 0830 THE PHYSICIAN ON DUTY INSERTED A 24 FR 3-WAY FOLEY CATHETER. PATIENT WAS THEN ADMITTED TO THE HOSPITAL. IN THE AFTERNOON OF (B)(6) 2017 THE ER PHYSICIAN PERFORMED AN EMERGENCY TURP TO RELIEVE THE SEVERE URINARY RETENTION AND STOP THE GROSS HEMATURIA WITH BLOOD CLOTS. AFTER THREE DAYS IN THE HOSPITAL THE PATIENT WAS SENT HOME TO CONTINUE RECOVERING WITH NO SERIOUS SIDE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241915 REZUM DELIVERY DEVICE KIT FOR BPH REZUM SYSTEM KNS NXTHERA INC. D2201-003 855357006010

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention