BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEGMENTED CYLINDER APPLICATOR SET

    MDR report key: 3289543 · Received August 8, 2013

    Report

    Report Number
    9612638-2013-00009
    Event Type
    Other
    Date Received
    August 8, 2013
    Date of Event
    November 6, 2011
    Report Date
    July 16, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE THAT WAS REPORTED IS CONSISTENT WITH THE INFO 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 PT'S BODY. PT MOVEMENT DURING TREATMENT OR BETWEEN PULSES CAN RESULT IN SIGNIFICANT FORCE APPLIED TO THE FLEXIBLE PROBE, WHEN THE SEGMENTED CYLINDER IS SECURED IN THE PT. THIS MAY NOT BE DETECTED IMMEDIATELY DURING PDR BRACHYTHERAPY DUE TO THE LONG TOTAL TREATMENT TIME (24-48 HOURS) WITHOUT CONSTANT PT 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 F/U TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED THAT THERE WAS A PT TREATED WITH THE GM11004150-SEGMENTED CYLINDER APPLICATOR SET, DURING A PDR TREATMENT, WHO DEVELOPED VAGINAL RADIATION ULCERS OUTSIDE THE EXPECTED TREATMENT AREA THAT MAY BE CONSISTENT WITH A SHIFTED FLEXIBLE PROBE. THIS WAS CONFIRMED BY BIOPSY. THE PT PLAN WAS FOR 28 PULSES OF 1GY. INSERTION CONSISTED OF 2 X 30MM, 1 X 25MM AND 1 X 20MM SEGMENTS WITH 3 DWELL POSITIONS, AT POSITIONS 1, 2 AND 3 EACH -136 SECS NORMAL TIME. THE CUSTOMER STATED THAT THERE WAS NO IMAGING AVAILABLE FOR THIS PT. NO FURTHER INFO WAS PROVIDED BY THE CUSTOMER. THE INCIDENT WAS REPORTED TO VARIAN MEDICAL SYSTEMS RETROSPECTIVELY BASED ON THE CUSTOMER SITE'S INTERNAL REVIEW OF PAST PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375470 SEGMENTED CYLINDER APPLICATOR SET BRACHYTHERAPY APPLICATOR JAQ VARIAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other