BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 15406944 · Received September 12, 2022

    Report

    Report Number
    3005099803-2022-05164
    Event Type
    Injury
    Date Received
    September 12, 2022
    Date of Event
    March 1, 2020
    Report Date
    September 12, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    PMA / PMN Number
    K181465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, (B)(6) 2020, WAS CHOSEN AS THE LITERATURE ARTICLE WAS RECEIVED FOR PUBLICATION ON 03/13/2021. THE COMPLAINANT WAS UNABLE TO REPORT THE UPN AND LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. INITIAL REPORTER HEALTH PROFESSIONAL: HEALTHCARE PROFESSIONAL WAS ESTIMATED TO YES BASED OFF EVENT DETAILS. LITERATURE SOURCE: MATSUGASUMI T, MASUI K, YAMADA K, WATANBE S, OKIHARA K, KOZAWA N, YAMADA Y, YAMAZAKI H, YAMADA K, UKIMURA O. CHALLENGE AND OUTCOME FOR THE PROSTATE SQUAMOUS CELL CARCINOMA WHICH DEVELOPED 8 YEARS AFTER LOW DOSE-RATE BRACHYTHERAPY APPROACHED BY A COMBINED MULTIMODAL TREATMENT WITH HIGH-DOSE-RATE INTERSTITIAL BRACHYTHERAPY, EXTERNAL BEAM RADIATION THERAPY, AND CHEMOTHERAPY. CASE REP ONCOL 2021;14:854-860; DOI: 10.1159/000516034. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS 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 · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE FOLLOWING EVENT FROM REFERENCED LITERATURE ARTICLE "CHALLENGE AND OUTCOME FOR THE PROSTATE SQUAMOUS CELL CARCINOMA WHICH DEVELOPED 8 YEARS AFTER LOW-DOSE-RATE BRACHYTHERAPY APPROACHED BY A COMBINED MULTIMODAL TREATMENT WITH HIGH-DOSE-RATE INTERSTITIAL BRACHYTHERAPY, EXTERNAL BEAM RADIATION THERAPY, AND CHEMOTHERAPY". IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UNKNOWN SPACEOAR DEVICE WAS IMPLANTED DURING A SPACEOAR IMPLANT PROCEDURE ON AN UNKNOWN DATE. AFTER THE IMPLANT PROCEDURE, IT WAS NOTED THAT BLEEDING WAS MINIMAL. NO PERIOPERATIVE COMPLICATIONS OCCURRED. SIX MONTHS AFTER THE PATIENT'S RADIATION TREATMENT, THE PATIENT COMPLAINED OF PERINEAL PAIN AND GAS TURBIDITY IN THE URINE. MAGNETIC RESONANCE IMAGING (MRI) DETECTED A NEWLY DEVELOPED PROSTATIC-RECTAL FISTULA. INFLAMMATION WAS ALSO REPORTED. A COLOSTOMY WAS PERFORMED TO RELIEVE THE PATIENT'S PAIN AND INFLAMMATION. THE PATIENT RECEIVED HIGH-DOSE-RATE (HDR) INTERSTITIAL BRACHYTHERAPY (ISBT) AT 25 GY WHICH WAS PERFORMED IN 5 FRACTIONS FOR 2 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810882 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention