BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 11757758 · Received April 30, 2021

    Report

    Report Number
    3005099803-2021-02015
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    March 1, 2021
    Report Date
    April 30, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    UDI-DI
    00864661000102
    PMA / PMN Number
    K181465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 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 MDR 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) 2021. FIDUCIALS WERE ADMINISTERED TRANSPERINEALLY PRIOR TO SPACEOAR IMPLANTATION AND THE PROCEDURE WAS DONE UNDER LOCAL ANESTHESIA. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY POSITIONING THE NEEDLE DUE TO PATIENT VERY LARGE RECTAL HUMP AND PROSTATE. THE IMAGES TAKEN POST PROCEDURE SHOWED THAT THE IMPLANT LOOKED GREAT FROM THE APEX THROUGH MIDGLAND AND THEN TOWARDS THE BASE, FROM 12 TO 3 O'CLOCK, THERE WAS A WISP THAT COULD BE RECTAL WALL IN THE MIDDLE OF THE GEL THAT APPEARED TO BE ATTACHED ONLY AT THE 3 O'CLOCK POSITION. THE RADIOLOGIST READ IT AS DISSECTION WITH UNDER 25% CIRCUMFERENTIAL INVOLVEMENT OF THE ANTERIOR RECTAL WALL AND LESS THAN 2.5 CC OF HYDORGEL WAS NOTED IN THE RECTAL WALL. THE PATIENT WILL FOLLOW THROUGH WITH THE PLANNED RADIATION TREATMENT AND WILL RECEIVE EXTERNAL BEAM RADIATION THERAPY (EBRT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647551 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION SO-2101 00864661000102

    Patients

    Seq Age Sex Outcome Treatment
    1