BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 7047730 · Received November 20, 2017

    Report

    Report Number
    3008550999-2017-00003
    Event Type
    Injury
    Date Received
    November 20, 2017
    Date of Event
    October 24, 2017
    Report Date
    November 20, 2017
    Manufacturer
    AUGMENIX, INC.
    Product Code
    OVB
    UDI-DI
    00864661000102
    PMA / PMN Number
    DEN140030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A HIGH RISK PROSTATE CANCER PATIENT WAS BEING TREATED WITH COMBINATION HDR/IMRT RADIATION THERAPY FOR A POSTERIOR TUMOR WITH EXTRACAPSULAR EXTENSION ABUTTING THE RECTAL WALL. THE PHYSICIAN FELT THAT TUMOR RETRACTION DURING HORMONE THERAPY MAY HAVE CREATED A VOID OR COMPROMISE OF THE RECTAL WALL. PHYSICIAN DID NOT BELIEVE THAT THE FISTULA WAS CAUSED BY THE HYDROGEL SPACER WHICH WAS LIKELY ABSORBED AT LEAST 3 MONTHS PRIOR TO THIS EVENT OCCURENCE. ON OCTOBER 31, 2017, AUGMENIX REPRESENTATIVE VISITED COMPLAINANT PHYSICIAN AND CONFIRMED THAT THE PHYSICIAN CHOSE NOT TO USE THE REQUIRED "STEPPER" TO STABILIZE THE US PROBE DURING HYDROGEL PLACEMENT. THE SPACEOAR IFU REQUIRES THAT A "STEPPER" BE USED FOR HYDROGEL PLACEMENT. PHYSICIAN WAS ORIGINALLY TRAINED USING THE STEPPER AS INDICATED IN THE IFU. AUGMENIX MEDICAL ADVISOR REVIEWED THE INFORMATION AND BELIEVES THAT IN THEORY THE PATIENT FISTULA COULD BE RELATED TO NOT USING THE REQUIRED STEPPER , RESULTING IN PROBE INSTABILITY AND HYDROGEL MISAPPLICATION DURING SPACER PLACEMENT. IN (B)(6) 2017 PATIENT PRESENTED WITH URETHRAL SYMPTOMS WITH INFLAMMATORY URETHRITIS. AFTER THIS THE PATIENT CALLED STATING THAT PUS WAS DRAINING FROM HIS PENIS. AFTER PRESENTING TO THE CLINIC CONFIRMATION WAS MADE THAT URINE COULD ONLY VACATE THROUGH THE RECTUM.

    Description of Event or Problem · 1

    PATIENT RECEIVED HYDROGEL SPACER AND UNDERWENT PROSTATE COMBINATION RADIOTHERAPY (HDR BRACHYTHERAPY DELIVERED IN (B)(6) 2017 AND IMRT IN (B)(6) 2017). FOLLOWING CONCLUSION OF IMRT TREATMENT PATIENT STOPPED ATTENDING ROUTINE FOLLOW-UP VISITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826951 SPACEOAR SYSTEM HYDROGEL SPACER OVB AUGMENIX, INC. SO-2101 UNKNOWN 00864661000102

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention