BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 9953298 · Received April 13, 2020

    Report

    Report Number
    3005099803-2020-01628
    Event Type
    Injury
    Date Received
    April 13, 2020
    Date of Event
    March 1, 2020
    Report Date
    May 20, 2020
    Manufacturer
    AUGMENIX, INC.
    Product Code
    OVB
    UDI-DI
    00864661000102
    PMA / PMN Number
    K181465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, (B)(6) 2020, WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT, . BLOCKS D4 AND H4: THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: PATIENT CODE 3191 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF HOSPITALIZATION. PATIENT CODE 1610 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF UNCONSCIOUSNESS REQUIRING HOSPITALIZATION. PATIENT CODE 2661 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF VAGO-VASAL RESPONSE REQUIRING HOSPITALIZATION. PATIENT CODE 1862 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF FISTULA. EVALUATION CONCLUSION CODE 4316 IS BEING USED IN LIEU OF AN ADEQUATE CONCLUSION CODE FOR DEVICE NOT RETURNED. BLOCK H10: 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 · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPACEOAR WAS IMPLANTED DURING A SPACEOAR HYDROGEL PROCEDURE PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THE PROCEDURE WAS PERFORMED UNDER LOCAL ANESTHETIC AND THREE GOLD ANCHOR FIDUCIAL MARKERS WERE PLACED IN THE PROSTATE PRIOR TO THE SPACEOAR PLACEMENT. IT WAS REPORTED THAT THE GOLD SEEDS WERE TOUGH TO PLACE BECAUSE THERE WAS NOT MUCH TISSUE TO PLACE THE GOLD SEEDS IN AFTER TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) WAS PERFORMED. THE SEEDS WERE STILL PLACED SUCCESSFULLY. THE PROCEDURE WAS REPORTED TO HAVE GONE SMOOTHLY WITH NO NOTICEABLE DIFFICULTY DISSECTING THE TISSUE OR INJECTING THE GEL. ACCORDING TO THE COMPLAINANT, FIVE MINUTES AFTER THE COMPLETION OF THE SPACEOAR INJECTION, THE PATIENT EXPERIENCED A VASOVAGAL REACTION. THE PATIENT PASSED OUT AND REGAINED CONSCIOUSNESS MULTIPLE TIMES WHILE BEING ATTENDED TO BY STAFF. THE PATIENT WAS TRANSFERRED TO THE EMERGENCY ROOM AND WAS GIVEN INTRAVENOUS (IV) FLUIDS UNTIL STABLE. THE PATIENT HAD MINIMAL DISCOMFORT POST PROCEDURE AND HAD THE FEELING OF SITTING ON SOMETHING. A COMPUTERIZED TOMOGRAPHY SIMULATION (CT SIM) WAS DONE A WEEK AFTER THE PROCEDURE, NO ABNORMALITIES WERE OBSERVED. THE PATIENT WAS PRESCRIBED STANDARD 79.2GY INTENSITY MODULATED RADIATION THERAPY (IMRT). REPORTEDLY, EIGHT DAYS INTO IMRT TREATMENT, THE PATIENT COMPLAINED OF FREQUENT AND URGENT URINATION. THE PATIENT REPORTED THAT DURING URINATION, SPOTS OF AIR DISCHARGED THROUGH PENIS. ACCORDING TO THE PATIENT, DURING URINATION, FLUID/URINE WOULD DISCHARGE FROM THE PATIENT'S RECTUM. A CT SCAN WAS DONE, AND A SMALL POCKET OF AIR WAS OBSERVED IN BETWEEN THE RECTUM AND PROSTATE. THE CT SHOWS A FISTULA TRACK FROM 1.4CM PROXIMAL TO THE ANAL VERGE TO THE BLADDER. REPORTEDLY, THE PATIENT WILL BE GOING IN FOR MAGNETIC RESONANCE IMAGING (MRI) AND HAS STARTED A STANDARD COURSE OF ANTIBIOTICS. NO FEVER AND NO SIGN OF INFECTION WERE RECORDED. THE PATIENT WAS ALSO TAKEN OFF DAILY RADIATION TREATMENTS UNTIL FURTHER SCANS CAN BE MADE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2020. THE PATIENT UNDERWENT SUPRAPUBIC TUBE PLACEMENT (SPT) AND HAD DIVERTING COLOSTOMY. WHEN THE SPT WAS PLACED, THE SIZE OF THE FISTULA WAS NOTED AS SUBSTANTIAL ON THE CYSTOSCOPY SCAN. THE PATIENT HAS BEEN PUT ON ANDROGEN DEPRIVATION THERAPY (ADT) AND IS REPORTED TO CONTINUE THIS TREATMENT FOR SEVERAL MONTHS.

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, (B)(6) 2020, WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT, (B)(6) 2020. THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE 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 HYDROGEL PROCEDURE PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THE PROCEDURE WAS PERFORMED UNDER LOCAL ANESTHETIC AND THREE GOLD ANCHOR FIDUCIAL MARKERS WERE PLACED IN THE PROSTATE PRIOR TO THE SPACEOAR PLACEMENT. IT WAS REPORTED THAT THE GOLD SEEDS WERE TOUGH TO PLACE BECAUSE THERE WAS NOT MUCH TISSUE TO PLACE THE GOLD SEEDS IN AFTER TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) WAS PERFORMED. THE SEEDS WERE STILL PLACED SUCCESSFULLY. THE PROCEDURE WAS REPORTED TO HAVE GONE SMOOTHLY WITH NO NOTICEABLE DIFFICULTY DISSECTING THE TISSUE OR INJECTING THE GEL. ACCORDING TO THE COMPLAINANT, FIVE MINUTES AFTER THE COMPLETION OF THE SPACEOAR INJECTION, THE PATIENT EXPERIENCED A VASOVAGAL REACTION. THE PATIENT PASSED OUT AND REGAINED CONSCIOUSNESS MULTIPLE TIMES WHILE BEING ATTENDED TO BY STAFF. THE PATIENT WAS TRANSFERRED TO THE EMERGENCY ROOM AND WAS GIVEN INTRAVENOUS (IV) FLUIDS UNTIL STABLE. THE PATIENT HAD MINIMAL DISCOMFORT POST PROCEDURE AND HAD THE FEELING OF SITTING ON SOMETHING. A COMPUTERIZED TOMOGRAPHY SIMULATION (CT SIM) WAS DONE A WEEK AFTER THE PROCEDURE, NO ABNORMALITIES WERE OBSERVED. THE PATIENT WAS PRESCRIBED STANDARD 79.2GY INTENSITY MODULATED RADIATION THERAPY (IMRT). REPORTEDLY, EIGHT DAYS INTO IMRT TREATMENT, THE PATIENT COMPLAINED OF FREQUENT AND URGENT URINATION. THE PATIENT REPORTED THAT DURING URINATION, SPOTS OF AIR DISCHARGED THROUGH PENIS. ACCORDING TO THE PATIENT, DURING URINATION, FLUID/URINE WOULD DISCHARGE FROM THE PATIENT'S RECTUM. A CT SCAN WAS DONE, AND A SMALL POCKET OF AIR WAS OBSERVED IN BETWEEN THE RECTUM AND PROSTATE. THE CT SHOWS A FISTULA TRACK FROM 1.4CM PROXIMAL TO THE ANAL VERGE TO THE BLADDER. REPORTEDLY, THE PATIENT WILL BE GOING IN FOR MAGNETIC RESONANCE IMAGING (MRI) AND HAS STARTED A STANDARD COURSE OF ANTIBIOTICS. NO FEVER AND NO SIGN OF INFECTION WERE RECORDED. THE PATIENT WAS ALSO TAKEN OFF DAILY RADIATION TREATMENTS UNTIL FURTHER SCANS CAN BE MADE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416504 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB AUGMENIX, INC. SO-2101 00864661000102

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R