BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 16979541 · Received May 22, 2023

    Report

    Report Number
    3005099803-2023-02642
    Event Type
    Injury
    Date Received
    May 22, 2023
    Date of Event
    April 1, 2023
    Report Date
    May 22, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    PMA / PMN Number
    K181465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: BASED ON THE DATE WHEN THE LITERATURE WAS PUBLISHED. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE UPN AND LOT NUMBER OF THE SUSPECT DEVICE; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK G2: KAM, JONATHAN; KISSANE, LUKE; MAKARY, JOSH; HANNA, BISHOY; JACKSON, STUART; MCCLINTOCK, GEORGE; GRANT, ALICE; ARIANAYAGAM, MOHAN; CANAGASINGHAM, BERTRAM; FERGUSON, RICHARD; GOOLAM, AHMED; WINTER, MATTHEW; KO, RAYMOND; MEHAN, NICHOLAS; THANGASAMY, ISAAC; KHADRA, MOHAMED; VAROL, CELI; AZZI, MARIA; JEFFERY, NICOLA PD15-09 REAL WORLD ASSESSMENT OF MRI PREDICTORS OF RECTAL COMPLICATIONS FOLLOWING TRANSPERINEAL SPACEOAR HYDROGEL INSERTION, JOURNAL OF UROLOGY: APRIL 2023 - VOLUME 209 - ISSUE SUPPLEMENT 4 DOI: 10.1097/JU.0000000000003262.09. BLOCK H6: DEVICE CODE A1502 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF GEL MISPLACED NON-VASCULAR. PATIENT CODE (B)(6) IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ULCER.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF AN EVENT THROUGH THE ARTICLE "PD15-09 REAL WORLD ASSESSMENT OF MRI PREDICTORS OF RECTAL COMPLICATIONS FOLLOWING TRANSPERINEAL SPACEOAR HYDROGEL INSERTION" WRITTEN BY JONATHAN KAM, ET AL. PER THE ARTICLE "PD15-09 REAL WORLD ASSESSMENT OF MRI PREDICTORS OF RECTAL COMPLICATIONS FOLLOWING TRANSPERINEAL SPACEOAR HYDROGEL INSERTION" IT WAS REPORTED THAT MULTIPLE PATIENTS WERE STUDIED, A RETROSPECTIVE AUDIT OF ALL MEN WHO UNDERWENT TRANSPERINEAL SPACEOAR HYDROGEL INSERTION FROM JANUARY 1,2017 TO JUNE 30, 2021, PRIOR TO RADIOTHERAPY FOR PROSTATE CANCER WAS PERFORMED. IT WAS REPORTED THAT A PATIENT EXPERIENCED A GRADE THREE RECTAL WALL INFILTRATION (RWI) AS A RESULT OF SPACEOAR PLACEMENT PROCEDURE. THE PATIENT ALSO DEVELOPED A RECTAL ULCER. ADDITIONAL INFORMATION RECEIVED ON MAY 4, 2023, STATED THAT THE PATIENT UNDERWENT A PROSTATECTOMY AS A RESULT OF HIS RADIATION TREATMENT BEING DELAYED. IT WAS NOTED THAT THE PATIENT DID NOT WANT TO DELAY HIS RADIATION TREATMENT UNTIL THE RECTAL ULCER HAD HEALED. AT THIS TIME NO OTHER INFORMATION WAS ABLE TO BE OBTAINED. THE STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781260 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R