BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 16949972 · Received May 17, 2023

    Report

    Report Number
    3005099803-2023-02684
    Event Type
    Malfunction
    Date Received
    May 17, 2023
    Date of Event
    January 1, 2017
    Report Date
    May 17, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    PMA / PMN Number
    K181465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCKS D4 AND 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: IMDRF DEVICE CODE A1502 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF GEL MISPLACED NON-VASCULAR.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF MULTIPLE EVENTS 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. ACCORDING TO THE LITERATURE, IT WAS REPORTED THAT 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 TOTAL OF ONE HUNDRED AND FORTY-ONE PATIENTS WERE STUDIED. A TOTAL OF THIRTY-SIX PATIENTS EXPERIENCED A RECTAL WALL INFILTRATION (RWI). OF ALL THIRTY-SIX PATIENTS WITH RWI, TWENTY OF THEM EXPERIENCED A GRADE ONE RWI, NINE OF THEM EXPERIENCED A GRADE TWO RWI, AND SEVEN OF THEM EXPERIENCED A GRADE THREE RWI. IT WAS ALSO INDICATED THAT THREE OUT OF THE SEVEN PATIENTS WITH GRADE THREE RWI, ALSO EXPERIENCED RECTAL COMPLICATIONS. TWO PATIENTS DEVELOPED A RECTAL ULCER, AND ONE PATIENT EXPERIENCED A RECTOURETHRAL FISTULA. OF THE TWO PATIENTS WHO DEVELOPED A RECTAL ULCER, ONE OF THEM RESULTED IN A DELAYED TREATMENT BY THREE MONTHS. THE STATUS OF THE PATIENTS IS UNKNOWN. NOTE: REFER TO MANUFACTURER REPORT NUMBER 3005099803-2023-02642 FOR THE REMAINING PATIENT THAT ALSO DEVELOPED A RECTAL ULCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1894402 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Male