BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR VUE SYSTEM

    MDR report key: 18773571 · Received February 23, 2024

    Report

    Report Number
    2124215-2024-08504
    Event Type
    Injury
    Date Received
    February 23, 2024
    Date of Event
    December 1, 2023
    Report Date
    February 23, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    PMA / PMN Number
    K182971
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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, 12/01/2023, WAS CHOSEN AS THE BEST ESTIMATE BASED ON THE DATE THE ARTICLE WAS PUBLISHED. 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 ARNOLD, PJ ET AL. IDENTIFICATION AND REPAIR OF RECTAL INJURY DURING DA VINCI PROSTATECTOMY WITH PRIOR SPACEOAR PLACEMENT. VIDEOUROLOGY (2023); 37(1). BLOCK H6: IMDRF PATIENT CODE E2015 CAPTURES THE REPORTABLE EVENT OF TISSUE DAMAGE.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING A SPACEOAR HYDROGEL DEVICE THROUGH THE ARTICLE, IDENTIFICATION AND REPAIR OF RECTAL INJURY DURING DA VINCI PROSTATECTOMY WITH PRIOR SPACEOAR PLACEMENT, WRITTEN BY PETER J, ARNOLD, MD ET AL. PER THE ARTICLE, THE PATIENT UNDERWENT A RADICAL PROSTATECTOMY PERFORMED WITH INTUITIVE SURGICAL DA VINCI XI-ROBOT ASSISTED; THE PROCEDURE WAS PERFORMED 75 DAYS AFTER SPACEOAR PLACEMENT. THE POSTERIOR DISSECTION PLANES WERE SIGNIFICANTLY DISTORTED DURING THE PROCEDURE BECAUSE OF THE SPACEOAR, A RECTAL INJURY WAS IDENTIFIED, AND GENERAL SURGERY WAS CONSULTED INTRAOPERATIVELY. THE INJURY WAS CLOSED AS THERE WAS NO FIELD CONTAMINATION, PRIMARILY IN TWO LAYERS WITHOUT DIVERSION WITH AN OVERLYING PERITONEAL FLAP. A SIGMOIDOSCOPY WAS THEN PERFORMED INTRAOPERATIVELY, WHICH REVEALED A WATERTIGHT CLOSURE. NO FURTHER COMPLICATIONS WERE EXPERIENCED DURING THE REST OF THE PROCEDURE. IT WAS NOTED THAT THE TISSUE DISTORTION WAS CAUSED BY THE SPACEOAR PREVIOUSLY PLACED. THE PATIENT WAS DISCHARGED HOME ON THE POSTOPERATIVE DAY AND CONTINUES TO DO WELL AS OF THIS MOST RECENT FOLLOW-UP, TWO YEARS POSTOPERATIVE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION DESPITE GOOD-FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130222 SPACEOAR VUE SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention