BEUDAMED
    FDA Adverse Event Other Summary report: N

    IODINE (I-125) SEEDS

    MDR report key: 4272011 · Received November 6, 2014

    Report

    Report Number
    2915056-2014-00013
    Event Type
    Other
    Date Received
    November 6, 2014
    Date of Event
    January 1, 2013
    Report Date
    October 14, 2014
    Product Code
    KXK
    PMA / PMN Number
    K914281
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: WE UNDERSTAND THAT AFTER LOW DOSE RATE (LDR) BRACHYTHERAPY THE PATIENT DEVELOPED RECTAL ULCER WHICH WAS BIOPSIED AND SUBSEQUENTLY DEVELOPED A RECTAL FISTULA. BIOPSY OF THE ANTERIOR RECTAL WALL IS CONTRAINDICATED AFTER BRACHYTHERAPY. THIS CONTRAINDICATION WAS RECOGNIZED OVER 10 YEARS AGO EARLY PRECISELY DUE TO REPORTS OF RECTAL FISTULA PURSUANT TO ANTERIOR RECTAL WALL BIOPSY AND / OR CAUTERIZATION. IT HAS BEEN WIDELY REPORTED IN THE MEDICAL LITERATURE. THE AUTHOR OF THE ABSTRACT SEEMS TO ACKNOWLEDGE THIS IN THE LAST PARAGRAPH. THE AMERICAN BRACHYTHERAPY SOCIETY GUIDELINES (ABC) PUBLISHED IN 2012 CLEARLY STATES THAT: "THE USE OF CAUTERY TO TREAT RECTAL BLEEDING, OR BIOPSIES TO EVALUATE ANOMALIES IN THE RECTUM, MAY RESULT IN THE DEVELOPEMENT OF LATROGENIC RECTOURETHRAL FISTULAS POST-PPB. THE ABC RECOMMENDS THAT SUCH PROCEDURES BE AVOIDED IF POSSIBLE.

    Description of Event or Problem · 1

    REPORT # 2915056-2014-00013 IS A LITERATURE REPORT FROM (B)(6) THAT INVOLVES A (B)(6) YEAR OLD MALE WHO EXPERIENCED SEVERE RECTAL ULCER, ARTERIAL BLEEDING, RADIATION PROCTITIS AFTER ADMINISTRATION OF IODINE (I-125) SEEDS FOR BRACHYTHERAPY FOR THE INDICATION OF PROSTATE CANCER. CONCURRENT MEDICAL CONDITIONS/PAST MEDICAL HISTORY INCLUDED PROSTATE CANCER. CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) 2011, THE PATIENT RECEIVED AN IMPLANT ADMINISTRATION OF IODINE (I-125) SEEDS FOR THE PROCEDURE. THE PATIENT WAS TREATED WITH A COMBINATION OF EXTERNAL BEAM RADIATION. THE RADIATION PROCTITIS DIAGNOSED BY COLONOSCOPY WAS OBSERVED. PSA 8.4NG/ML, PROSTATE VOLUME 32ML, BIOPSY PATHOLOGY GLEASON SCORE 3+4=7 (RIGHT 7/19, LEFT 0/22) WITH A CLINICAL DIAGNOSIS OF CT1CN0M0. THE PATIENT UNDERWENT BRACHYTHERAPY (MONO THERAPY) WITH THE INSERTION OF 80 SEEDS. HE WAS DISCHARGED WITHOUT COMPLICATIONS DURING SURGERY AND POSTOPERATIVELY. IN (B)(6) 2013, HE EXPERIENCED PAIN WITH DEFECATION AND VISITED A NEARBY HOSPITAL. THERE WAS EVIDENCE OF RECTAL ULCER COLONOSCOPY, CONSERVATIVE TREATMENT AFTER THE BIOPSY ENFORCEMENT. WITHOUT IMPROVEMENT IN CONSERVATIVE TREATMENT IN (B)(6) 2013, THE PATIENT VISITED THE REPORTER'S HOSPITAL. A STATE WAS CLOSE TO THE RECTAL PERFORATION, S-SHAPED COLON COLOSTOMY ENFORCEMENT IN (B)(6) 2013. BY BLOODY STOOL, THE COLONOSCOPY ENFORCEMENT IN (B)(6) 2013. ARTERIAL BLEEDING WAS OBSERVED BUT CLIPPING HEMOSTASIS WAS DIFFICULT, THEN ANGIOGRAPHY AND EMBOLIZATION WAS ENFORCED. AFTER THAT THERE WAS NO BLEEDING BUT WITHOUT ULCER IMPROVEMENT, THE REPORTER WAS CONSIDERING HYPERBARIC OXYGEN THERAPY IN THE FUTURE. FOR RADIATION PROCTITIS AND RECTAL ULCER AFTER PROSTATE BRACHYTHERAPY, THE REPORTER RECOGNIZED THAT WELL-KNOWN IS IMPORTANT TO ENDOSCOPISTS, INCLUDING THE PRINCIPLE CONTRAINDICATIONS BIOPSY AND EXPLANATION TO THE PATIENT. YAMAZAKI MUTSUSHI ET AL; ONE CASE OF SEVERE RECTAL ULCER CAUSED BY RADIATION PROCTITIS AFTER PERMANENT INSERTION BRACHYTHERAPY FOR PROSTATE CANCER . THE 79TH ANNUAL MEETING OF THE EASTERN SECTION OF JAPANESE UROLOGICAL ASSOCIATION OCT 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713130 IODINE (I-125) SEEDS NONE KXK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| O