BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEEDLE CLICKFIT TRANSFER GUIDE TUBE SET

    MDR report key: 3170542 · Received June 5, 2013

    Report

    Report Number
    9612638-2013-00007
    Event Type
    Other
    Date Received
    June 5, 2013
    Date of Event
    March 27, 2013
    Report Date
    May 15, 2013
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    JAQ
    PMA / PMN Number
    K113766
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THIS SITUATION, THE SITE USED THE INCORRECT TRANSFER GUIDE TUBE AND DID NOT PERFORM THE REQUIRED MEASUREMENTS TO ENSURE THAT THE APPROPRIATE LENGTH TRANSFER TUBE WAS UTILIZED. AS A RESULT, THE PATIENT WAS TREATED MORE PROXIMALLY (ANTERIOR VAGINA INSTEAD OF THE CERVIX). THIS ERROR HAS BEEN DETERMINED TO BE ENTIRELY A CUSTOMER USE ERROR ISSUE AND NOT DUE TO MALFUNCTION OF A VARIAN PRODUCT. NO FURTHER FOLLOW UP TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT A MEDICAL EVENT OCCURRED ON (B)(6) 2013. THE USER STATED THE WRONG TRANSFER GUIDE TUBE WAS USED DURING 3 OF 4 HDR [HIGH-DOSE RATE BRACHYTHERAPY] TREATMENTS. THE ERROR WAS DISCOVERED AFTER THE THIRD TREATMENT. THE SITE'S RADIATION SAFETY OFFICER (RSO) STATED THAT THE DESIRED AREA OF TREATMENT WAS UNDER DOSED BY MORE THAN 50%. THE TREATMENT PLAN PRESCRIBED 2400 CGY OVER 4 TREATMENTS. HE STATED THAT THE PATIENT AND THEIR PHYSICIAN WERE NOTIFIED AS SOON AS THE ERROR WAS DISCOVERED. ON (B)(6) 2013, THE SITE PROVIDED THE FOLLOWING INFORMATION TO THE NRC: THE PHYSICIST OF RECORD RETRIEVED TUBE CONNECTORS FROM THE HDR SUPPLIES ON SHELVES IN THE DOSIMETRY AREA. THE TUBE/CONNECTORS WERE STORED, COILED IN ZIPLOC BAGS. THE PHYSICIST SELECTED GREEN TUBES WHEN HE SAW THE BLACK TUBES USED PREVIOUSLY WERE NOT ON THE SHELF. HE WAS UNAWARE THAT THERE WERE TWO SETS, EACH A DIFFERENT LENGTH WHEN HE SELECTED THE GREEN SET. THE BLACK TUBES MEASURE 120CM IN LENGTH AND THE GREEN TUBES MEASURE 132CM. THE SENIOR PHYSICIST, WHO WAS ON VACATION DURING THE FIRST TWO OUT OF THE FOUR TREATMENTS, STORED THE BLACK TUBE SET IN A DRAWER ACROSS THE ROOM. PHYSICIST SELECTED TUBES WHICH ATTACHED TO THE PATIENT'S TREATMENT DEVICE. THE PHYSICIST PLANNED THE PATIENT'S TREATMENT WITH THE TREATMENT LENGTHS (119.9 CM) STATED IN THE SITE'S HDR TANDEM AND RING TREATMENT PLANNING PROCEDURE AND FORMS, BUT USED THE 132CM TUBE FOR THE TREATMENT DELIVERY FOR THREE OUT OF FOUR FRACTIONS. ONLY THE BLACK TUBES WERE USED HISTORICALLY IN TANDEM AND RING HDR PROCEDURES AND SINCE THEIR GIVEN LENGTH WERE KNOWN, THEY WERE NOT MEASURED AT THE TIME OF TREATMENT DELIVERY. THE GREEN TUBES WERE ALSO NOT MEASURED PRIOR TO TREATMENT DELIVERY. THE PHYSICIAN OF RECORD SAW THE GREEN TUBES AND BELIEVED THEIR USE WAS INTENTIONAL. THIS MEDICAL EVENT MEANT THE PATIENT'S TISSUE TO BE TREATED (CERVIX) RECEIVED LESS TOTAL RADIATION DOSE THAN THAT PRESCRIBED: 1,390 CGY (MEAN DOSE DELIVERED) VS. THE 5,139 CGY THE CERVIX WOULD HAVE RECEIVED OVER THE FOUR TREATMENTS. THIS IS MORE THAN A 50 CGY (50 REM) EFFECTIVE DOSE EQUIVALENT DIFFERENCE TO THE CERVIX. IN ADDITION, THE MEAN TOTAL DOSE DELIVERED TO THE CERVIX OVER THE FOUR TREATMENTS DIFFERED FROM THE PRESCRIBED DOSE BY MORE THAN 20% (42.1% IS THE ACTUAL VARIANCE) AND THE DELIVERED DOSE FOR AT LEAST ONE OF THE FRACTIONS DIFFERED BY MORE THAN 50% FROM THE PRESCRIBED DOSE (FRACTION #1 CERVIX MEAN DOSE DELIVERED WAS 42.5 CGY VS. THE 1,192.4 CGY EXPECTED) (FRACTION #2 CERVIX MEAN DOSE DELIVERED WAS 34.6 CGY VS. THE 1,416.3 CGY EXPECTED) AND (FRACTION #3 CERVIX MEAN DOSE DELIVERED WAS 45.2 CGY VS. THE 1,262.2 CGY EXPECTED). THE PATIENT'S URETHRA RECEIVED A MEAN DOSE OF 1,607 CGY FOR THE FOUR FRACTIONS. THE MAXIMUM DOSE TO 1 CC OF THE URETHRA FOR THE FOUR FRACTIONS WAS 1,849 CGY. THE PATIENT'S ANTERIOR VAGINA RECEIVED A MEAN DOSE FROM THE FOUR FRACTIONS OF 1,549 CGY. THE MAXIMUM DOSE TO 1 CC OF THE ANTERIOR VAGINA FOR THE FOUR FRACTIONS WAS 3,049 CGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249151 NEEDLE CLICKFIT TRANSFER GUIDE TUBE SET REUSABLE TRANSFER GUIDE TUBES JAQ VARIAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other