BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 9269056 · Received November 1, 2019

    Report

    Report Number
    3005099803-2019-05257
    Event Type
    Injury
    Date Received
    November 1, 2019
    Date of Event
    October 5, 2019
    Report Date
    November 1, 2019
    Manufacturer
    AUGMENIX, INC.
    Product Code
    OVB
    PMA / PMN Number
    K181465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: DATE THE ARTICLE WAS PUBLISHED. EXACT DATE OF EVENT IS UNKNOWN. THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. REPORT SOURCE: LITERATURE SOURCE: HOE, VENETIA, ET AL. "ABSCESS FORMATION FOLLOWING HYDROGEL SPACER FOR PROSTATE CANCER RADIOTHERAPY: A RARE COMPLICATION." BMJ CASE REPORTS CP 12.10 (2019): E229143. DOI: HTTP://DX.DOI.ORG/10.1136/BCR-2018-229143. (B)(4). THE DEVICE WAS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF AN EVENT THROUGH THE ARTICLE "ABSCESS FORMATION FOLLOWING HYDROGEL SPACER FOR PROSTATE CANCER RADIOTHERAPY: A RARE COMPLICATION" WRITTEN BY VENETIA HOE, ET AL. ACCORDING TO THE ARTICLE, PRIOR TO A COURSE OF EXTERNAL BEAM RADIOTHERAPY (EBRT) FOR AN EARLY ORGAN-CONFINED PROSTATE CANCER, SPACEOAR WAS IMPLANTED ALONG WITH THREE GOLD FIDUCIALS. CONVENTIONAL ANTIBIOTIC PROPHYLAXIS (CEPHAZOLIN) WAS GIVEN FOR THIS PROCEDURE. A FEW WEEKS AFTER COMPLETING THE COURSE OF EBRT, THE PATIENT PRESENTED TO THE HOSPITAL WITH PURULENT URETHRAL DISCHARGE, ANAL PAIN, A FEVER AND A 5 KG WEIGHT LOSS. UPON EXAMINATION, THE PATIENT WAS FEBRILE AT 38.1 DEGREES CELSIUS WITH A HEART RATE OF 105 BEATS/MIN AND BLOOD PRESSURE 135/85 MM HG. THE PATIENT'S ABDOMEN WAS SOFT BUT ACUTELY TENDER IN THE SUPRAPUBIC REGION, AND PROSTATE GLAND WAS TENDER WITH NO EVIDENCE OF PUS OR BLOOD IN THE RECTUM. TESTING REVEALED AN ELEVATED WHITE CELL COUNT OF 13X109/L AND A C-REACTIVE PROTEIN OF 149 MG/L. AN ABDOMINOPELVIS COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A 54X35X75 MM COLLECTION IN THE LOCATION OF SPACEOAR. SUBSEQUENT CT CYSTOGRAM DID NOT REVEAL ANY FISTULOUS CONNECTION BETWEEN THE COLLECTION AND THE BLADDER. THE PATIENT WAS ASSESSED AS MOST LIKELY HAVING A PERIPROSTATIC ABSCESS. DIFFERENTIAL DIAGNOSIS ALSO INCLUDED A RECTAL FISTULA GIVEN THE PATIENT'S HISTORY OF ULCERATIVE COLITIS AND RECENT EBRT TREATMENT; HOWEVER, A SIGMOIDOSCOPY WAS PERFORMED TO EXCLUDE FISTULOUS COMMUNICATION INTO THE RECTUM. ULTRASOUND-GUIDED TRANSPERINEAL PERCUTANEOUS DRAINAGE WAS PERFORMED AND A DRAIN TUBE INSERTED INTO THE PERIPROSTATIC ABSCESS. FORTY CUBIC CENTIMETRES OF PURULENT FLUID WAS ASPIRATED AND SENT FOR MICROSCOPY AND CULTURE. A PIGTAIL DRAIN WAS INSERTED FOR CONTINUAL DRAINAGE. ABSCESS FLUID CULTURED SENSITIVE FOR STREPTOCOCCUS ANGINOSUS AND ANAEROBES. THE PATIENT WAS TREATED WITH A PROLONGED 5-WEEK COURSE OF ANTIBIOTICS. AT DAY 14, DRAIN OUTPUT CEASED AND THE PIGTAIL DRAIN WAS REMOVED. SUBSEQUENT SERIAL CT SCANS DEMONSTRATED A REDUCTION IN SIZE OF THE COLLECTION OVER THE INTERVENING 2 MONTHS TO 26 X 27 X1 5 MM. THE PATIENT REMAINED WELL OFF ANTIBIOTICS WITH NO FURTHER FEVERS, PAIN OR URINARY SYMPTOMS ON FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063099 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB AUGMENIX, INC. SO-1010

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention