BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 10093683 · Received May 27, 2020

    Report

    Report Number
    3005099803-2020-01988
    Event Type
    Injury
    Date Received
    May 27, 2020
    Date of Event
    April 28, 2020
    Report Date
    May 27, 2020
    Manufacturer
    AUGMENIX, INC.
    Product Code
    OVB
    PMA / PMN Number
    K181465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPACEOAR WAS IMPLANTED DURING A SPACEOAR PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, FIDUCIAL SEEDS WERE PLACED BY TRIMODALITY, TRANSPERINEALLY PRIOR TO SPACEOAR IMPLANTATION. THE PROCEDURE WAS DONE UNDER LUMBAR ANESTHESIA. IT WAS NOTED THAT THE SPACE MADE BY HYDRODISSECTION SEEMED SMALLER COMPARED TO THE USUAL PROCEDURE AND THERE WAS A SLIGHT BULGING UPON HYDRODISSECTION. THE PATIENT ALSO UNDERWENT EXTERNAL BEAM RADIATION THERAPY (EBRT) ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, TWO RECTAL ULCERS WERE NOTED AROUND THE SPACEOAR PLACEMENT. ON (B)(6) 2020, THE PATIENT HAD BLOODY DISCHARGE, NO FEVER, AND THERE WAS INFLAMMATORY REACTION EVEN ON BLOOD SAMPLING. ON (B)(6) 2020, A RECTOSCOPY WAS PERFORMED, AND A COMPUTERIZED TOMOGRAPHY SCAN (CT) WAS ALSO PERFORMED DURING THIS TIME. AS OF (B)(6) 2020, THE PHYSICIAN CONFIRMED ON MAGNETIC RESONANCE IMAGING (MRI) THAT THE SPACEOAR HAD STRAYED IN THE RECTAL WALL 3 WEEKS AFTER PLACEMENT. THE PATIENT WAS TREATED WITH HYPERBARIC OXYGEN THERAPY FOR ONE MONTH BEGINNING ON (B)(6) 2020, AND WAS ALSO TREATED WITH STEROID SUPPOSITORY AND A LAXATIVE PRESCRIPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555241 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB AUGMENIX, INC. SO-4101

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention