BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 17642980 · Received August 29, 2023

    Report

    Report Number
    3005099803-2023-04588
    Event Type
    Injury
    Date Received
    August 29, 2023
    Date of Event
    August 1, 2023
    Report Date
    August 29, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    PMA / PMN Number
    K181465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, (B)(6), 2023, WAS CHOSEN AS THE BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT, (B)(6), 2023. BLOCKS D4 AND H4: THE COMPLAINANT WAS UNABLE TO REPORT THE UPN/LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK G2: LITERATURE SOURCE: MCMANUS, A ET AL. SPACER GEL EROSION THROUGH THE RECTAL WALL. A CASE REPORT DETAILING AN UNFORTUNATE SIDE EFFECT OF THE PROTECTIVE TREATMENT OF PROSTATE CANCER DURING RADIOTHERAPY. SURGICAL ENDOSCOPY (2023). 37: S436. HTTPS://DOI.ORG/10.1007/S00464-023-10072-3. BLOCK H6: IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF HEMORRHAGE. IMDRF PATIENT CODE E2330 CAPTURES THE REPORTABLE EVENT OF PAIN. IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT GEL MISPLACED - NON VASCULAR.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING AN SPACEOAR DEVICE THROUGH THE ARTICLE SPACER GEL EROSION THROUGH THE RECTAL WALL. A CASE REPORT DETAILING AN UNFORTUNATE SIDE EFFECT OF THE PROTECTIVE TREATMENT OF PROSTATE CANCER DURING RADIOTHERAPY, BY MCMANUS, A ET AL. PER THE ARTICLE A PATIENT DIAGNOSED WITH PROSTATE CANCER, UNDERWENT INJECTION OF A SPACEOAR HYDROGEL, AFTER THE PROCEDURE THE PATIENT STARTED RADIOTHERAPY. THE PATIENT UNDERWENT SEVERAL ROUNDS OF RADIATION THERAPY, BUT THE PLACEMENT OF THE RADIATION SEEDS WAS UNSUCCESSFUL. THE PATIENT BEGAN EXPERIENCING PAIN, HEMATOCHEZIA AND STRAINING WITH SMALLER THAN NORMAL CALIBER STOOL FOR TWO WEEKS, THE EVENT SENT THE PATIENT TO THE EMERGENCY ROOM (ER). COMPUTED TOMOGRAPHY (CT) SCAN SHOWED A LOW ATTENUATING STRUCTURE IN THE RECTAL WALL, THIS WAS EVALUATED FURTHER BY MAGNETIC RESONANCE IMAGING (MRI). THE PATIENT RECEIVED A SIGMOIDOSCOPY, WHICH DEMONSTRATED A SMALL EROSION OF THE ANTERIOR RECTAL WALL WITH A GELATINOUS MASS EXTRUDING INTO THE LUMEN, ALTHOUGH NOT OBSTRUCTIVE, CONSISTENT WITH THE HYDROGEL SPACER. DEBAKEY FORCEPS WAS PLACED ONTO THE FOREIGN BODY, THE SUPERFICIAL PORTION OF THE MASS CAME APART EASILY AND HOWEVER, THE DEEPER PORTION WAS SURROUNDED BY INFLAMMATION AND WAS LEFT IN PLACE. THE PATIENT WAS KEPT IN OBSERVATION AND TREATED WITH ANTIBIOTICS. ANOTHER SIGMOIDOSCOPY WAS PERFORMED THREE WEEKS LATER, AND NO HYDROGEL SPACER WAS FOUND. THE PATIENT CURRENT CONDITION WAS UNKNOWN. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000420 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention| H