BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL STUMP APPLICATOR SET

    MDR report key: 7108626 · Received December 11, 2017

    Report

    Report Number
    MW5073915
    Event Type
    Injury
    Date Received
    December 11, 2017
    Date of Event
    November 16, 2017
    Report Date
    December 8, 2017
    Manufacturer
    VARIAN MEDICAL SYSTEMS INC., ONCOLOGY SYSTEMS
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OUR DEPARTMENT AT PRESENCE CANCER CENTER IN (B)(6). WE TREAT PATIENTS WITH HIGH DOSE RATE (HDR) IR-(B)(4) RADIOACTIVE SOURCES FOR THE TREATMENT OF GYNECOLOGICAL CANCERS. IN (B)(6) 2017, WE ACQUIRED A DEVICE FROM VARIAN MEDICAL SYSTEMS WHICH IS AN APPLICATOR USED IN THE DELIVERY OF THE RADIOACTIVE SOURCE IN A SAFE AND CONTROLLED MANNER. THE PRODUCT # IS GM 1011160 AND IS CALLED A UNIVERSAL STUMP APPLICATOR. THE APPLICATOR IS INSERTED INTO THE PATIENT AND A PLAN IS MADE TO DETERMINE HOW LONG THE SOURCE IS TO REMAIN IN THE AFFECTED AREA FOR SAFE AND COMPLETE TREATMENT. PRIOR TO TREATMENT THE TREATMENT IN SIMULATED DURING A CT SCAN TO ASSURE PROPER PLACEMENT. WITH THIS APPLICATOR A RIGID GUIDE TUBE IS INCLUDED AND INSERTED INTO THE CENTER OF THE APPLICATOR. IT IS A BLIND END DEVICE TO CONTAIN THE SOURCE IN CASE THE RADIOACTIVE SEED WOULD BREAK OFF DURING TREATMENT. THE RIGID GUIDE TUBE IS HELD IN PLACE WITH A TYPE OF COMPRESSION FITTING. DURING SIMULATION OF THIS PATIENT WE NOTICED THAT THE RIGID GUIDE TUBE EXTENDED BEYOND THE APPLICATOR DEVICE ITSELF FURTHER INTO THE PATIENT ANATOMY. THIS WOULD PERMIT A HIGH INTENSITY RADIOACTIVE SOURCE TO IRRADIATE A PATIENT WITHOUT THE PROTECTION OR ATTENUATION OF THE APPLICATOR MATERIAL. AS A RESULT WE DID NOT CONTINUE USE OF THE PRODUCT WITH THIS PARTICULAR PATIENT. WE DID REALIZE HOWEVER THAT WE HAD GIVEN A PREVIOUS PATIENT ONE TREATMENT WITH THIS DEVICE WITHOUT KNOWING WHETHER OR NOT THE RIGID GUIDE TUBE EXTENDED ITSELF FURTHER INTO THE PATIENT. SUBSEQUENT EVALUATION OF THE PATIENT REVEALED NO "UNTOWARD" REACTION ON THE PART OF THE PATIENT AND THEREFORE IT WAS AGREED THAT THIS DID NOT OCCUR IN THIS PARTICULAR PATIENTS TREATMENT. IF IT HAD, THE PATIENT WOULD HAVE RECEIVED A SERIOUS MISADMINISTRATION OF DOSE AND THERE WOULD HAVE BEEN A RATHER SEVERE REACTION. WE SUBSEQUENTLY REMOVED THE DEVICE FROM USE AND HAVE SENT IT BACK TO THE MANUFACTURER FOR THEIR EVALUATION. WE BELIEVE THIS DEVICE HAS GREAT POTENTIAL FOR HARM AS THERE IS A NO WAY OF ASSESSING WHETHER OR NOT THE RIGID GUIDE TUBE IS IN THE PROPER POSITION. THIS DEVICE IS DESIGNED TO BE PLACED IN THE VAGINA OF A PATIENT AND THERE ARE NO INDICATIONS IN PERMANENT MARKS OR DETENTES WHICH WILL INDICATE THAT THE RIGID GUIDE TUBE IS IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883957 UNIVERSAL STUMP APPLICATOR SET SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED JAQ VARIAN MEDICAL SYSTEMS INC., ONCOLOGY SYSTEMS GM1011160 R38

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention