BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 11684953 · Received April 19, 2021

    Report

    Report Number
    3005099803-2021-01774
    Event Type
    Injury
    Date Received
    April 19, 2021
    Date of Event
    March 18, 2021
    Report Date
    April 19, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    UDI-DI
    00864661000102
    PMA / PMN Number
    K181465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 AND THE PROCEDURE WAS DONE UNDER GENERAL ANESTHESIA. FEW DAYS AFTER THE PROCEDURE, THE PATIENT DEVELOPED DISCOMFORT, PAIN AND URINARY RETENTION. THE PHYSICIAN PRESCRIBED FLOWMAX AND ANTIBIOTICS BUT THE PATIENT SYMPTOMS DID NOT GO AWAY. MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED AND IT SHOWED THAT THE SPACEOAR WAS IN THE CORRECT PLACE, AT THE BASE TOWARDS MIDGLAND. AT THE APEX, THERE APPEARED TO BE A TINY AREA OF POSSIBLE INTRAPROSTATIC INJECTION WITH POSSIBLY GEL MOVING AROUND TO THE LATERAL APEX, POSSIBLY THROUGH VENOUS POOLS. ADDITIONALLY, THE URINARY RETENTION AND DISCOMFORT WERE CAUSED BY THE SPACEOAR GEL INSIDE THE GLAND THAT CAUSED PRESSURE ON THE URETHRA. THE PHYSICIAN STATED THAT HE WOULD EXPECT PATIENT URINATION TO IMPROVE IN ABOUT 2 WEEKS WITH SUPPORTIVE CARE SUCH AS INCREASED FLOMAX AND MEDROL DOSE PACK WOULD BE AN OPTION. THE PATIENT HAS ALREADY STARTED EXTERNAL BEAM RADIATION THERAPY (EBRT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586187 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION SO-2101 00864661000102

    Patients

    Seq Age Sex Outcome Treatment
    1 Other