BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 7650104 · Received June 29, 2018

    Report

    Report Number
    3008550999-2018-00003
    Event Type
    Death
    Date Received
    June 29, 2018
    Date of Event
    April 29, 2018
    Report Date
    June 4, 2018
    Manufacturer
    AUGMENIX, INC.
    Product Code
    OVB
    UDI-DI
    008646610000102
    PMA / PMN Number
    DEN140030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING ADDITIONAL FOLLOW UP WITH THE COMPLAINANT ON 06/JUN/2018, THE FOLLOWING TIMELINE OF EVENTS WAS REPORTED. PATIENT RECEIVED SPACEOAR AND HDR PROCEDURE ON (B)(6) 2018. ON (B)(6) 2018, PATIENT PRESENTED WITH UTI, A FEVER OF 103 AND COUGH DEHYDRATION. THE PATIENT WAS TREATED WITH IV FLUIDS AND ANTIBIOTICS. ON (B)(6) 2018, THE PATIENT WAS ADMITTED TO THE ICU WITH SEPSIS. THE PATIENT HAD A SUPRAPUBIC CATHETER PLACED (PROSTATIC ABSCESS WAS IDENTIFIED AND DRAINED) AND THE PATIENT HAD A NEPHROLOGY CONSULT REGARDING RENAL FAILURE. ON (B)(6) 2018, THE PATIENT PRESENTED WITH ATRIAL FIBRILLATION. ON (B)(6) 2018, CARE WAS WITHDRAWN AND THE PATIENT PASSED AWAY ON (B)(6) 2018. PRELIMINARY CAUSE OF DEATH WAS NOTED AS ALCOHOLIC CARDIOMYOPATHY. THE SEPSIS AND INFECTION WERE NOTED AS RESOLVED AT THE TIME OF DEATH. COMPLAINANT DOES NOT BELIEVE THAT THE INFECTION IS RELATED TO SPACEOAR. THERE WAS NO INDICATION OF RECTAL WALL INJECTION OR VASCULAR UPTAKE OF GEL REPORTED. COMPLAINANT INDICATED THAT THE SPACEOAR GEL APPEARED TO BE IN THE CORRECT SPACE AND INTACT BETWEEN THE RECTUM AND PROSTATE ON CTS TAKEN AFTER THE PROCEDURE AND DURING SUBSEQUENT INTERVENTIONS. REVIEW OF THE DEVICE HISTORY RECORD FOR LOT 01161801 INDICATE THAT THE DEVICES WERE MANUFACTURED TO SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE MET.

    Description of Event or Problem · 1

    ON 09/APR/2018, AUGMENIX REPRESENTATIVE LEARNED THAT A PATIENT HAD AN INFECTION AND URINARY RETENTION FOLLOWING HDR PROCEDURE AND SPACEOAR PLACEMENT. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND A SUPRA-PUBIC CATHETER WAS PLACED. DURING CATHETER PLACEMENT, A TRANS-URETHRAL INCISION WAS MADE AND IT WAS NOTED THAT THE PATIENT HAD A PROSTATIC ABSCESS. THE COMPLAINANT INFORMED US THAT THE SITE MEDICAL TEAM DID NOT BELIEVE THE INFECTION WAS RELATED TO SPACEOAR. DURING A FOLLOW-UP CONVERSATION WITH THE COMPLAINANT ON 04/JUN/2018, IT WAS REPORTED THAT A PATIENT WAS NOT DISCHARGED FROM THE HOSPITAL AND HAD PASSED AWAY ON (B)(6) 2018. IT WAS REPORTED THAT THE PRELIMINARY CAUSE OF DEATH IS ALCOHOLIC CARDIOMYOPATHY. AT THE TIME OF DEATH, THE SEPSIS AND INFECTION WERE RESOLVED. THE BLADDER OUTLET, RENAL FAILURE AND PROSTATE CANCER WERE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494422 SPACEOAR SYSTEM HYDROGEL SPACER OVB AUGMENIX, INC. 01161801 008646610000102

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death