BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 12024812 · Received June 18, 2021

    Report

    Report Number
    3005099803-2021-02903
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    May 1, 2021
    Report Date
    June 18, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    UDI-DI
    00864661000102
    PMA / PMN Number
    K181465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, (B)(6) 2021, WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT, (B)(6) 2021. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. (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 WAS IMPLANTED DURING A SPACEOAR PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE PLACEMENT WAS PERFORMED UNDER SEDATION. DURING THE PROCEDURE, THE PLACEMENT WENT NORMALLY WITH NO TRAUMA AND FINE HYDRODISSECTION. THE PHYSICIAN STATES THAT, "WHEN THE SPACEOAR WAS DEPLOYED IT SEEMED LIKE IT WENT HIGH AND NOTHING WENT BACKWARDS". THE PATIENT HAD PERINEAL PAIN AFTER THE PROCEDURE, WHICH RESOLVED, BUT HE CONTINUES TO HAVE FEELINGS OF INCOMPLETE EMPTYING WITH BOWEL MOVEMENTS AND URINARY FREQUENCY/URGENCY. LATER THAT NIGHT THE PATIENT WENT INTO URINARY RETENTION. HAD A FOLEY CATHETER PLACED AND IT WAS KEPT IN PLACE UNTIL THE MAGNETIC RESONANCE IMAGING (MRI) SIMULATION. ON MAGNETIC RESONANCE IMAGING (MRI) SIMULATION, THE PHYSICIAN SAW A STREAK GOING DOWN TOWARDS THE GENITOURINARY (GU) AND THEN A SPOT AT THE PENILE BULB. THE RADIOLOGIST THINKS IT COULD BE SPACEOAR OR BLOOD OR URINE FROM TRAUMA. THE PATIENT WAS ABLE TO URINATE ON HIS OWN AFTER THE FOLEY CATHETER WAS PULLED OUT. THEY WAITED A MONTH TO SEE IF IT WOULD RESOLVE. ON REPEAT IMAGING, THE PATIENT REMAINED SYMPTOMATIC WITH BOWEL AND URINE URGENCY. ON FOLLOW-UP MRI TODAY IT APPEARED THERE WAS SPACEOAR IN THE PENILE BULB. THE PATIENT HAS FAVORABLE INTERMEDIATE RISK DISEASE AND WANTS TO PROCEED WITH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919699 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION SO-2101 00864661000102

    Patients

    Seq Age Sex Outcome Treatment
    1