BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 10011755 · Received April 29, 2020

    Report

    Report Number
    3005099803-2020-01824
    Event Type
    Malfunction
    Date Received
    April 29, 2020
    Date of Event
    March 18, 2020
    Report Date
    May 21, 2020
    Manufacturer
    AUGMENIX, INC.
    Product Code
    OVB
    UDI-DI
    00864661000102
    PMA / PMN Number
    K181465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCKS D4 AND H4: THE LOT NUMBER IS NOT KNOWN PER THE COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED. BLOCK H6: THE DEVICE CODE 3009 IS USED TO CAPTURE THE REPORTABLE EVENT OF GEL MISPLACED NON-VASCULAR. 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 GEL WAS IMPLANTED DURING A SPACEOAR HYDROGEL PLACEMENT PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT MAY HAVE SOME DEGREE OF RECTAL WALL INFILTRATION. REPORTEDLY, MAGNETIC RESONANCE IMAGING (MRI) SHOWS THE PLACEMENT IS SATISFACTORY AND RADIATION TREATMENT WILL PROCEED AS PLANNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. *ADDITIONAL INFORMATION RECEIVED ON MAY 7, 2020* IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPACEOAR GEL WAS IMPLANTED DURING A SPACEOAR HYDROGEL PLACEMENT PROCEDURE ON MARCH 18, 2020. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS PUT UNDER SEDATION PRIOR TO THE PROCEDURE. THERE WERE NO REPORTED COMPLICATIONS OR VISUALIZATION ISSUES DURING THE PROCEDURE. REPORTEDLY, A SMALL AMOUNT OF GEL WAS INJECTED INTO THE RECTAL WALL. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE FINE. REPORTEDLY, THE PATIENT HAS PROCEEDED WITH TREATMENT.

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED DATE, (B)(6) 2020, WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT, 04/06/2020. THE LOT NUMBER IS NOT KNOWN PER THE COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED. (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 GEL WAS IMPLANTED DURING A SPACEOAR HYDROGEL PLACEMENT PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT MAY HAVE SOME DEGREE OF RECTAL WALL INFILTRATION. REPORTEDLY, MAGNETIC RESONANCE IMAGING (MRI) SHOWS THE PLACEMENT IS SATISFACTORY AND RADIATION TREATMENT WILL PROCEED AS PLANNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. 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
    472330 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB AUGMENIX, INC. SO-2101 00864661000102

    Patients

    Seq Age Sex Outcome Treatment
    1