MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS, INC. UNIVERSAL STUMP APPLICATOR SET BRACHYTHERAPY VAGINAL CYLINDER; SYSTEMS, APPLICATOR, RADIONUCLIDE REMOTE CONTROLLED

Model Number GM11011160

Device Problem Malposition of Device (2616)

Patient Problems Wound Dehiscence (1154); Discomfort (2330)

Event Date 04/30/2019

Event Type  Injury  

Event Description

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.

• Brand Name: UNIVERSAL STUMP APPLICATOR SET BRACHYTHERAPY VAGINAL CYLINDER
• Type of Device: SYSTEMS, APPLICATOR, RADIONUCLIDE REMOTE CONTROLLED
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS, INC.
• MDR Report Key: 8632343
• MDR Text Key: 146051106
• Report Number: MW5086830
• Device Sequence Number: 1
• Product Code: JAQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GM11011160
• Device Catalogue Number: GM11011160
• Device Lot Number: T24
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 57 YR