UNIVERSAL STUMP APPLICATOR SET BRACHYTHERAPY VAGINAL CYLINDER GM11011160

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-21 for UNIVERSAL STUMP APPLICATOR SET BRACHYTHERAPY VAGINAL CYLINDER GM11011160 manufactured by Varian Medical Systems, Inc..

Event Text Entries

[146051106] Pt was planned to have a brachytherapy boost with a vaginal cylinder beginning on (b)(6) 2019. Speculum examination performed prior to procedure showed a well healed vaginal cuff without evidence of cuff separation or tumor implantation. Vaginal cylinder (cylinder shaped applicator 3 cm diameter x 14 cm length) was prepared by nursing staff. The applicator was covered with contrast agent followed by placement of a condom sheath. The pt was then positioned supine and the vaginal cylinder was inserted by the physician until there was an increase in resistance. The pt complained of some discomfort with the insertion. The vaginal cylinder and rod was then fastened to clamp in the base plate underneath pt's buttock to ensure stability of the device. A ct was then performed of the pelvic area where the cylinder was found to be higher than expected and associated with a pocket of air at the superior aspect of the device. It was thought that the cylinder was mispositioned and therefore was re-positioned prior to another ct scan to confirm correct placement. Unfortunately, the second scan re-demonstrated the aforementioned abnormality. The applicator was removed. There was no evidence the condom sheath had been ruptured. The pt went to use the restroom and shortly afterwards found a mass protruding from her vagina. The pt was transported to the emergency dept. This was later determined to be bowel. The pt underwent an emergent trans-vaginal repair of the cuff dehiscence within a few hours of notification and was discharged home that same night. Images were reviewed on (b)(6) 2019 where it was found that the center piece (rod) of the vaginal cylinder was displaced upwards relative to the cylinder. This may have precipitated or contributed to vaginal cuff dehiscence. We believe that it would be beneficial to make a design change of the device not to allow the protrusion of rod above the cylinder to prevent future incidence of vaginal cuff dehiscence.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5086830
MDR Report Key8632343
Date Received2019-05-21
Date of Report2019-05-15
Date of Event2019-04-30
Date Added to Maude2019-05-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameUNIVERSAL STUMP APPLICATOR SET BRACHYTHERAPY VAGINAL CYLINDER
Generic NameSYSTEMS, APPLICATOR, RADIONUCLIDE REMOTE CONTROLLED
Product CodeJAQ
Date Received2019-05-21
Model NumberGM11011160
Catalog NumberGM11011160
Lot NumberT24
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerVARIAN MEDICAL SYSTEMS, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2019-05-21

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