BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIR-SPHERES MICROSPHERES

    MDR report key: 5019118 · Received August 8, 2015

    Report

    Report Number
    9710358-2015-00002
    Event Type
    Injury
    Date Received
    August 8, 2015
    Date of Event
    July 14, 2015
    Report Date
    August 7, 2015
    Manufacturer
    SIRTEX MEDICAL LIMITED
    Product Code
    NAW
    PMA / PMN Number
    P990065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT OCCURRED DUE TO INABILITY OF USER TO MAINTAIN CORRECT PLACEMENT OF DELIVERY CATHETER, RESULTING IN SIR-SPHERES MICROSPHERES BEING INCORRECTLY DELIVER TO THE SMALL BOWEL. HE DELIVERY CATHETER WAS A BOSTON SCIENTIFIC RENEGADE HI-FLO CATHETER WHICH WAS NOT SUPPLIED WITH THE SIR-SPHERES MICROSPHERES. NO SURGICAL INTERVENTION REQUIRED AT TIME OF REPORT. SIRTEX WILL CONTINUE TO PROVIDE EXTENSIVE TRAINING ON THE USE OF SIR-SPHERES MICROSPHERES TO CUSTOMERS, INCLUDING ON PROPER CATHETER PLACEMENT TECHNIQUES. NO FURTHER CORRECTIVE OR PREVENTIVE ACTION CONSIDERED NECESSARY.

    Description of Event or Problem · 1

    UPON INITIAL (FIRST) ALIQUOT OF SIRSPHERES DELIVERY, THE IR NOTICED THAT CATHETER HAD MIGRATED BACK INTO THE SMA. HE STOPPED INFUSION IMMEDIATELY. HE SUSPECTED THAT BASED ON WHERE THE CATHETER WAS WHEN HE CHECKED FLOURO, THAT THERE WAS A HIGH PROBABILITY THAT ACTIVITY WOULD HAVE MADE IT TO THE SMALL BOWEL. NUC MED IMAGING CONFIRMED THIS. HE SOUGHT AND RECEIVED CONSULTATION FROM SEVERAL HIGH VOLUME Y90 USERS/PROCTORS ON HOW TO BEST MITIGATE POTENTIAL ADVERSE SIDE EFFECTS, AND HOW BEST TREAT AND FOLLOW THE PATIENT. BY THE NEXT MORNING THE NUC MED TEAM HAD ESTIMATED THAT APPROX. 7.8 MCI OF Y90 WAS DELIVERED TO SMALL BOWEL. AT THE TIME OF THIS REPORT, NO SURGICAL INTERVENTION HAS BEEN REQUIRED. PROPHYLACTIC MEDICATIONS WERE RECOMMENDED BY PROCTORS AS WELL AS MEDICAL DIRECTOR. IN ADDITION, AN AGGRESSIVES SURVEILLANCE PROGRAM WAS SUGGESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521283 SIR-SPHERES MICROSPHERES YTTRIUM 90 RESIN MIROSPHERES NAW SIRTEX MEDICAL LIMITED SIR-Y001

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization