BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLETCHER-SUIT DELCLOS (FSD) STYLE APPLICATOR SET

    MDR report key: 2456831 · Received February 1, 2012

    Report

    Report Number
    9612638-2012-00001
    Event Type
    Other
    Date Received
    February 1, 2012
    Date of Event
    January 4, 2012
    Report Date
    January 31, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    JAQ
    PMA / PMN Number
    K952913
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED ON INFORMATION RECEIVED FROM A THIRD PARTY OR DEVELOPED BY VARIAN MEDICAL SYSTEMS. WHILE THE REPORTED EVENT IS BEING INVESTIGATED, SOME OF THE FACTS ARE AS YET UNVERIFIED. INFORMATION PROVIDED IN THIS REPORT IS BASED ON THE ASSUMPTION THAT THE INFORMATION CURRENTLY AVAILABLE IS TRUE AND ACCURATE. THE FOLLOWING EVALUATION CODES WERE USED: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. MECHANICAL TESTS PERFORMED. THE MISTREATMENT IS CONCLUDED TO BE THE RESULT OF DEPLOYMENT OF A DAMAGED TANDEM. THE DAMAGE TO THE TANDEM IS CONSISTENT WITH NOT PROPERLY DISASSEMBLING THE APPLICATOR SET. AN AREA OF "NECKING FROM THE ROUGH HANDLING IS APPARENT ON THE TANDEM AT THE POINT WHERE A TRANSFER GUIDE TUBE CANNOT PASS BEYOND. ADDITIONALLY THE USER DID NOT IDENTIFY THAT THE TRANSFER GUIDE TUBE WAS NOT DEPLOYED AT THE APPROPRIATE POSITION WHICH WOULD BE DETECTABLE VIA FOLLOWING INSTRUCTIONS, AS WELL AS FOLLOWING ADVICE TO USE AN X-RAY MARKER WIRE TO CONFIRM POSITIONING WITH AN IMAGE. NO ADDITIONAL FOLLOW UP OF THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT RETURNED FOR A TWO WEEK FOLLOW-UP APPOINTMENT WITH HER RADIATION ONCOLOGIST AND REPORTED A SKIN IRRITATION IN THE MEDIAL THIGH AREA. UPON EXAM THE RADIATION ONCOLOGIST NOTED AN UNEXPECTED AREA OF "ROUGH SKIN". THE PATIENT WAS PRESCRIBED (PRIOR FOLLOW-UP APPOINTMENTS) FOUR FRACTIONS OF HDR, TREATED TWICE PER WEEK. A CLINICAL TEAM AT USER SITE CONCLUDED THE MISTREATMENT OCCURRED WITH THE FOURTH AND FINAL FRACTION, DUE TO THE TIMING OF THE APPEARANCE OF SKIN REACTION. THE CLINICAL TEAM PERFORMED A DOSIMETRIC IMPACT ANALYSIS: 1200CGY DELIVERED TO THE SKIN OF THE THIGHS ALONG THE ACTIVE LENGTH CORRESPONDING TO THE PATIENT THIGHS CONSISTENT WITH THE SKIN REACTION OBSERVED. DELIVERED DOSE: 190CGY (INTENDED TOTAL DOSE OF 400 CGY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLETCHER-SUIT DELCLOS (FSD) STYLE APPLICATOR SET BRACHYTHERAPY APPLICATOR JAQ VARIAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other