BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEOAR VUE SYSTEM

    MDR report key: 11790734 · Received May 7, 2021

    Report

    Report Number
    3005099803-2021-02073
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    April 13, 2021
    Report Date
    June 9, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    PMA / PMN Number
    K182971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: MEDICAL DEVICE PROBLEM CODE A1502 CAPTURES THE REPORTABLE EVENT OF GEL MISPLACED, NON-VASCULAR. BLOCK H10: SPACEOAR DEVICE WAS RECEIVED FOR EVALUATION. VISUAL ANALYSIS OBSERVED THE DILUENT AND ACCELERATOR SYRINGES MOSTLY FILLED. THE Y-CONNECTOR WAS CLOGGED, LIKELY DUE TO THE ABORTED PROCEDURE. THE REPORTED COMPLAINT OF "GEL MISPLACED NON-VASCULAR" AND "INJECTION NEEDLE DIFFICULT TO POSITION" WERE UNABLE TO BE CONFIRMED INFORMATION FROM THE PROCEDURE SUGGESTS DECREASED VISIBILITY, WHICH WAS WORSENED BY 12 CC OF SALINE, CONTRIBUTED TO THE REPORTED MISPLACEMENT. BASED ON ALL GATHERED INFORMATION, THE COMPLAINT IS ASSIGNED A PROBABLE CAUSE OF ADVERSE EVENT RELATED TO PROCEDURE WHICH INDICATES THE ADVERSE EVENT OF NEEDLE DIFFICULTY TO POSITION OCCURRED DURING THE PROCEDURE AND THE DEVICE HAD NO INFLUENCE ON EVENT. DURING THE PROCEDURE THE PATIENT COMPLAINED OF PAIN AND THERE WAS MINOR HEMORRHAGE. REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE REPORTED ADVERSE EVENTS ARE KNOWN AND DOCUMENTED IN THE LABELING (INCLUDING BOTH SHORT OR LONG TERM KNOWN COMPLICATIONS OR ADVERSE REACTIONS). THEREFORE, THE MOST PROBABLE ROOT CAUSE IS KNOWN INHERENT RISK OF DEVICE. A DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMS THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A RISK REVIEW INDICATES THE REPORTED COMPLAINT OF "GEL MISPLACED NON-VASCULAR" IS DEFINED IN THE RISK DOCUMENTATION. A LABELING REVIEW WAS PERFORMED, AND THE REPORTED PATIENT EFFECTS ARE LISTED IN THE DFU AS POTENTIAL OUTCOMES OF THIS PROCEDURE. THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED IN ACCORDANCE WITH THE DFU.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPACEOAR VUE WAS IMPLANTED DURING A SPACEOAR VUE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. 4-D CONE-BEAM COMPUTED TOMOGRAPHY SYSTEM (CBCT) WAS DONE PRIOR TO SPACEOAR IMPLANTATION. ADDITIONALLY, THE NEEDLE WAS DIFFICULT TO POSITION AND THE PROCEDURE WAS DONE UNDER LOCAL ANESTHESIA. DURING PROCEDURE, THE ANATOMY WAS PARTICULARLY DIFFICULT TO CLEARLY IDENTIFY AND THE CASE QUICKLY BECAME MORE COMPLICATED WITH 12CC OF SALINE CLOUDING THE ULTRASOUND IMAGE. THE PLACEMENT WAS FINALLY CONFIRMED BUT DURING ASPIRATION, BLOOD WAS DETECTED AND THE PHYSICIAN REPOSITIONED THE NEEDLE TWICE. THE ASPIRATION WAS CLEAR AND THE DECISION TO PLACE SPACEOAR WAS MADE. AS SOON AS THE INJECTION BEGAN, THE PATIENT FELT A BURNING SENSATION AND ARTIFACT APPEARED TO HIGHLIGHT THE PROSTATE POSTERIORLY. THE CASE WAS IMMEDIATELY STOPPED WITH ONLY 1CC OF PRODUCT INJECTED. THE DECISION WAS MADE TO CANCEL THE CASE OUT OF AN ABUNDANCE OF CAUTION. ADDITIONALLY, THERE WAS A POTENTIAL PARTIAL GEL INJECTION INTO THE PROSTATE. THE BURNING SENSATION WAS TRANSIENT, LASTING ONLY 1 SECOND. NO PAIN TREATMENT WAS NEEDED. THE PATIENT WILL RECEIVE STEREOTACTIC BODY RADIATION THERAPY (SBRT).

    Additional Manufacturer Narrative · 1

    (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 VUE WAS IMPLANTED DURING A SPACEOAR VUE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. ADDITIONALLY, THE NEEDLE WAS DIFFICULT TO POSITION AND THE PROCEDURE WAS DONE UNDER LOCAL ANESTHESIA. DURING PROCEDURE, THE ANATOMY WAS PARTICULARLY DIFFICULT TO CLEARLY IDENTIFY AND THE CASE QUICKLY BECAME MORE COMPLICATED WITH 12CC OF SALINE CLOUDING THE ULTRASOUND IMAGE. THE PLACEMENT WAS FINALLY CONFIRMED BUT DURING ASPIRATION, BLOOD WAS DETECTED AND THE PHYSICIAN REPOSITIONED THE NEEDLE TWICE. THE ASPIRATION WAS CLEAR AND THE DECISION TO PLACE SPACEOAR WAS MADE. AS SOON AS THE INJECTION BEGAN, THE PATIENT FELT A BURNING SENSATION AND ARTIFACT APPEARED TO HIGHLIGHT THE PROSTATE POSTERIORLY. THE CASE WAS IMMEDIATELY STOPPED WITH ONLY 1CC OF PRODUCT INJECTED. THE DECISION WAS MADE TO CANCEL THE CASE OUT OF AN ABUNDANCE OF CAUTION. ADDITIONALLY, THERE WAS A POTENTIAL PARTIAL GEL INJECTION INTO THE PROSTATE. THE BURNING SENSATION WAS TRANSIENT, LASTING ONLY 1 SECOND. NO PAIN TREATMENT WAS NEEDED. THE PATIENT WILL RECEIVE STEREOTACTIC BODY RADIATION THERAPY (SBRT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690339 SPACEOAR VUE SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION SV-2101 0026770161

    Patients

    Seq Age Sex Outcome Treatment
    1