MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS HAAN GMBH GM11011160 UNIVERSAL STUMP APPLICATOR SET

Model Number GM11011160

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Rupture (2208)

Event Date 05/07/2019

Event Type  Injury  

Event Description

Female brachy therapy patient was undergoing brachy procedure.The patient was scheduled for fraction 1 of vaginal cylinder treatment. the applicator was placed and ct scan was completed.Patient experienced severe discomfort and the applicator was removed.The patient was then taken to the emergency room. the vaginal wall had ruptured and small bowel was protruding into the vagina.The patient was taken into surgery.After the incident occurred, the site reviewed the ct images and discovered the rigid guide tube had pushed out of the cylinder dome.The site physicians report that this caused the injury to the patient.

Event Description

See manufactures narrative.

Manufacturer Narrative

Varian conducted a conference with the site on (b)(6) 2019, to inquire about the patient¿s status and to gather information as part of complaint investigation.The following information was communicated to varian by the site representatives present: the case involved a patient with stage ia clear cell carcinoma of the endometrium.The misadministration was related to the intracavitary brachytherapy fraction #1).Prior to receiving brachytherapy, the patient had already completed a total abdominal hysterectomy with bilateral salpingo-oophorectomy (tah/bso) as well as 2 cycles of chemotherapy during the first brachytherapy procedure the patient experienced pain after the applicator was placed.No radiation was given for this fraction.The attending physician involved during the brachy procedure did not fully remove the cylinder.The site¿s ct scanner was not showing topograms that day, so they could only evaluate transverse slices.This made identification that the rigid guide tube had extended beyond the cylinder dome more difficult (and in this case, missed).Also, when the cylinder was explanted, the rigid guide tube was pulled back in to the cylinder, making it harder for the site to identify that the rigid guide tube was extended while in the patient.The patient was sent quickly to the emergency department and received treatment to close the wound and was discharged home that same day.Patient is healing well and will receive 2 more cycles of chemotherapy and the attending physician expects to perform brachytherapy once fully healed.Site will send the applicator back once their own risk mitigation process is finished.Varian¿s product manager observed the two ct datasets and there was no significant difference observed between the two ct¿s, before/after repositioning of the applicator performed by site during procedure; thus the site did not observe that the rigid guide tube was extending beyond the dome.Site indicated there were no unusual histologically indicators or otherwise (e.G., negative margins, no disease at suture line) that would cause reduced healing from the tah/bso procedure.Patient has stage ia clear cell endometrial cancer.Tah/bso was performed 1/29/19.Original plan was tah/bso, followed by chemo (2 cycles, followed by 3 fractions of brachytherapy; 7gy x 3 to 0.5cm followed by more chemo.Now the plan will be tah/bso, followed by chemo (2 cycles), followed by more chemo instead of brachy (2 cycles), followed by brachytherapy, followed by possibly more chemo.No external beam radiation was given to patient; only chemotherapy.Approximately three months had passed from tah/bso to the date of the incident, with the tah/bso done on (b)(6) 2019, and the incident on (b)(6) 2019.Multiple patients have been treated with this applicator with approximately 30 fractions had been given with this applicator prior to the planned use with this patient.David harrington (pm varian) was on site during conference and was able to assemble the applicator and it fixed nicely and seemed to be in perfect working order.Site uses steris plasma system to sterilize (off-label and not tested).Site communicated their workflow for the procedure as follows: the nursing staff assembles the applicator and performs any tests.The nursing staff then places the applicator in a condom that has some contrast solution within it.The physician assumes it is assembled correctly and performs no additional tests himself.Barium-sulfate contrast mix was used (same as is swallowed for gi imaging).Site described how they insert the applicator into the patient as follows: the physician pushes on the rigid guide tube until he feels resistance, or the patient feels discomfort.Site¿s procedure to immobilize the applicator: they clamp directly on the rigid guide tube with the clamping device.Type of surgery to repair perforation: simple closure with sutures.General anesthesia was required.This repair procedure was done on (b)(6) 2019 patient went home the same day.Site indicated no prior slippage of the rigid guide tube from the cylinder body had been observed.Site indicated no packing material was used during the brachy procedure and no catheter was in place during the procedure.Investigation ongoing.

Event Description

See mw-2019--00006.Mfr 9612638-2019-00001.

Manufacturer Narrative

Root cause: user performed insufficient manual tightening and testing of the clamping segment (per the instructions for use: ifu:), which allowed the rigid guide tube to slide within the applicator cylinder beyond the distal end when insertion force was applied to the rigid guide tube.Varian has addressed the issue with the site by stressing the requirements of the ifu regarding the proper tightening of the clamping segment.The ifu provides sufficient instructions to ensure the device is sufficiently tighten and then check the assembly of the applicator.If the user has not sufficiently tightened the clamping segment, the user/operator will see the rigid guide tube slip within the cylinder or cylinder segments while doing required checks from the ifu.A displaced rigid guide tube in the patient should be shown by the ct planning images.Although the device can be incorrectly tightened by the user, the risk indicated it would be unlikely to result in serious injury.There has been one reported instance of a perforated vaginal wall (this case) from an applicator of this design.The design has been in the field for 5 years, and there are approximately 600 operating sets globally.Varian has opened nc-2019-00253 which will review the need for any corrective actions.H3 other text : site declined to return device.

• Brand Name: GM11011160 UNIVERSAL STUMP APPLICATOR SET
• Type of Device: GM11011160 UNIVERSAL STUMP APPLICATOR SET
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS HAAN GMBH; bergische strasse 16; haan
• MDR Report Key: 8620141
• MDR Text Key: 145416197
• Report Number: 9612638-2019-00001
• Device Sequence Number: 1
• Product Code: HGD
• Combination Product (y/n): N
• PMA/PMN Number: K160516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 05/17/2019
• Supplement Dates Manufacturer Received: 05/15/2019; 05/15/2019
• Supplement Dates FDA Received: 06/24/2019; 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention