BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 9938203 · Received April 8, 2020

    Report

    Report Number
    3005099803-2020-01561
    Event Type
    Injury
    Date Received
    April 8, 2020
    Date of Event
    November 1, 2019
    Report Date
    June 11, 2020
    Manufacturer
    AUGMENIX, INC.
    Product Code
    OVB
    UDI-DI
    00864661000102
    PMA / PMN Number
    K181465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 1994 CAPTURES THE REPORTABLE EVENT OF PAIN REQUIRING TREATMENT WITH A CATHETER AND PRESCRIPTION OXYCODONE. 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

    ON MARCH 11, 2020 BOSTON SCIENTIFIC CORPORATION WAS MADE AWARE OF A PATIENT COMPLAINT VIA (B)(4). ACCORDING TO THE COMPLAINANT THE PATIENT RECEIVED SPACEOAR IN (B)(6) 2019. THE PATIENT REPORTEDLY HAS BEEN EXPERIENCING PAIN AND USING A CATHETER EVER SINCE THE PROCEDURE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION RECEIVED ON MAY 19, 2020. THE SPACEOAR PLACEMENT PROCEDURE WAS PERFORMED ON NOVEMBER 01, 2019. THE PATIENT WAS UNABLE TO URINATE AFTER RECEIVING SPACEOAR. A CATHETER WAS PLACED, AND IT WAS REMOVED THE NEXT DAY. ON NOVEMBER 3, 2019, THE PATIENT AGAIN COULD NOT URINATE. THE PHYSICIAN RECOMMENDED OVER THE COUNTER BLADDER MEDICATIONS BUT THE PATIENT REPORTED THAT THE PILLS DID NOT WORK. THE PATIENT STARTED TO EXPERIENCE PAIN IN THE KIDNEYS AND WENT TO THE EMERGENCY ROOM. A CATHETER WAS PLACED AND THE PATIENT KEPT THE CATHETER IN PLACE UNTIL NOVEMBER 12, 2019. REPORTEDLY, THE PATIENT'S SYMPTOMS DID NOT DELAY THE START OF THE RADIATION TREATMENT. ON NOVEMBER 21, 2019, THE PATIENT BEGAN RADIATION THERAPY (RT) WHILE STILL HAVING DIFFICULTY URINATING. AFTER THE FIRST 2 RT, A CATHETER WAS AGAIN PLACED FOR THE REMAINDER OF THE 45 TREATMENTS. THE RADIATION TREATMENT WAS COMPLETED ON JANUARY 24, 2020. THE PATIENT HAD SECOND ER VISIT DUE TO INABILITY TO EMPTY HIS BLADDER. A CATHETER WAS PLACED AND WAS LEFT IN FOR 5 WEEKS. THE CATHETER WAS REMOVED ON MARCH 24, 2020 AND UROLOGIST CONFIRMED THAT PATIENT WAS EMPTYING HIS BLADDER NORMALLY. AS OF MAY 19, 2020, THE PATIENT IS STILL EXPERIENCING SOME BURNING WITH URINATION. THE PATIENT ALSO STATED THAT THROUGHOUT THE APPROXIMATE 5 MONTH PERIOD OF SYMPTOMS, HE COULDN'T SIT FOR MORE THAN 3 OR 4 MINUTES. THE PATIENT TOOK PRESCRIPTION OXYCODONE FROM THE DATE OF THE PROCEDURE TO "ABOUT HALFWAY THROUGH THE ORDEAL" TO HELP HIM SLEEP. IN ADDITION, THE PATIENT ALSO HAD BOWEL ISSUES AFTER RECEIVING SPACEOAR AND NEEDED TO USE STOOL SOFTENERS POST-PROCEDURE AS HIS STOOLS WOULD COME OUT IN SMALL PIECES. AFTER STARING THE RADIATION THERAPY, THE PATIENT HAD TO STAND UP TO START BOWEL MOVEMENT AND THEN PARTIALLY SQUAT TO COMPLETE BOWEL MOVEMENT, THIS OCCURRED FOR 2-3 WEEKS. THE PATIENT ALSO WAS UNABLE TO HAVE A BOWEL MOVEMENT FULLY SEATED ON THE TOILET UNTIL ABOUT A MONTH AFTER TREATMENT WAS COMPLETED. BOWEL MOVEMENTS HAVE RESOLVED SINCE THE GEL DISSOLVED. THE UROLOGIST HAD THE PATIENT ON FLOMAX AND LUPRON PRIOR TO RECEIVING SPACEOAR.

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, (B)(6) 2019, WAS CHOSEN AS A BEST ESTIMATE BASED ON THE INFORMATION THAT THE PATIENT RECEIVED THE SPACEOAR IN (B)(6). 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

    ON MARCH 11, 2020 BOSTON SCIENTIFIC CORPORATION WAS MADE AWARE OF A PATIENT COMPLAINT VIA (B)(6). ACCORDING TO THE COMPLAINANT THE PATIENT RECEIVED SPACEOAR IN (B)(6) 2019. THE PATIENT REPORTEDLY HAS BEEN EXPERIENCING PAIN AND USING A CATHETER EVER SINCE THE PROCEDURE. 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
    403971 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB AUGMENIX, INC. SO-2101 00864661000102

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention