BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEGMENTED CYLINDER APPLICATOR SET

    MDR report key: 3170543 · Received June 5, 2013

    Report

    Report Number
    9612638-2013-00008
    Event Type
    Other
    Date Received
    June 5, 2013
    Date of Event
    January 1, 2013
    Report Date
    May 14, 2013
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    JAQ
    PMA / PMN Number
    K033371
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE THAT WAS REPORTED IS CONSISTENT WITH THE INFORMATION DETAILED IN VARIAN MEDICAL SYSTEMS COMPLAINT (B)(4), IN WHICH A CORRECTIVE ACTION HAS BEEN INITIATED TO INFORM THE USER TO CEASE USE OF THE GM11004150 FOR PDR TREATMENT AND TO REPLACE THE DEVICE WITH THE MODIFIED SHIELDED APPLICATOR SET, GM11004380. THE FLEXIBLE PROBE CAN SLIP IN THE GUIDE TUBE UNDER SUFFICIENT FORCE WHEN CORRECTLY ATTACHED TO THE GUIDE TUBE, WITH THE APPLICATOR SECURED IN THE PATIENT'S BODY. PATIENT MOVEMENT DURING TREATMENT OR BETWEEN PULSES CAN RESULT IN SIGNIFICANT FORCE APPLIED TO THE FLEXIBLE PROBE, WHEN THE SEGMENTED CYLINDER IS SECURED IN THE PATIENT. THIS MAY NOT BE DETECTED IMMEDIATELY DURING PDR BRACHYTHERAPY DUE TO THE LONG TOTAL TREATMENT TIME (24-48 HOURS) WITHOUT CONSTANT PATIENT MONITORING. THE CORRECTIVE ACTION WAS PREVIOUSLY REPORTED UNDER THE GUIDELINES OF 21 CFR PART 806 (RECALL #: Z-1324-2013; REFERENCE #: 9612638-04/19/2013-001R). NO FURTHER FOLLOW UP TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THEY WERE USING THE GM11004150 SEGMENTED CYLINDER APPLICATOR SET IN CONJUNCTION WITH A PDR TREATMENT AND EXPERIENCED AN ISSUE WITH THE FLEXIBLE PROBE, GM11002280-COMPONENT OF THE SEGMENTED CYLINDER APPLICATOR SET, SLIPPING DURING THE PDR TREATMENT. THE INCIDENT INVOLVED A POTENTIAL OF 2.0 CM DISPLACEMENT OF DOSE DURING 7 PULSES OF A PDR TREATMENT. IT IS NOT CLEAR WHEN THE SHIFT OCCURRED, BUT THERE WERE 7 PULSES WHERE IT COULD HAVE HAPPENED. THE SITE HAS DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249467 SEGMENTED CYLINDER APPLICATOR SET BRACHYTHERAPY APPLICATOR JAQ VARIAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other