UNIVERSAL STUMP APPLICATOR SET GM1011160

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-11 for UNIVERSAL STUMP APPLICATOR SET GM1011160 manufactured by Varian Medical Systems Inc., Oncology Systems.

Event Text Entries

[94694046] Our department at presence cancer center in (b)(6). We treat patients with high dose rate (hdr) ir-(b)(4) radioactive sources for the treatment of gynecological cancers. In (b)(6) 2017, we acquired a device from varian medical systems which is an applicator used in the delivery of the radioactive source in a safe and controlled manner. The product # is gm 1011160 and is called a universal stump applicator. The applicator is inserted into the patient and a plan is made to determine how long the source is to remain in the affected area for safe and complete treatment. Prior to treatment the treatment in simulated during a ct scan to assure proper placement. With this applicator a rigid guide tube is included and inserted into the center of the applicator. It is a blind end device to contain the source in case the radioactive seed would break off during treatment. The rigid guide tube is held in place with a type of compression fitting. During simulation of this patient we noticed that the rigid guide tube extended beyond the applicator device itself further into the patient anatomy. This would permit a high intensity radioactive source to irradiate a patient without the protection or attenuation of the applicator material. As a result we did not continue use of the product with this particular patient. We did realize however that we had given a previous patient one treatment with this device without knowing whether or not the rigid guide tube extended itself further into the patient. Subsequent evaluation of the patient revealed no "untoward" reaction on the part of the patient and therefore it was agreed that this did not occur in this particular patients treatment. If it had, the patient would have received a serious misadministration of dose and there would have been a rather severe reaction. We subsequently removed the device from use and have sent it back to the manufacturer for their evaluation. We believe this device has great potential for harm as there is a no way of assessing whether or not the rigid guide tube is in the proper position. This device is designed to be placed in the vagina of a patient and there are no indications in permanent marks or detentes which will indicate that the rigid guide tube is in place.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5073915
• MDR Report Key: 7108626
• Date Received: 2017-12-11
• Date of Report: 2017-12-08
• Date of Event: 2017-11-16
• Date Added to Maude: 2017-12-12
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: UNIVERSAL STUMP APPLICATOR SET
• Generic Name: SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
• Product Code: JAQ
• Date Received: 2017-12-11
• Returned To Mfg: 2017-11-27
• Model Number: GM1011160
• Lot Number: R38
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: VARIAN MEDICAL SYSTEMS INC., ONCOLOGY SYSTEMS
• Manufacturer Address: ATLANTA GA 30329 US 30329

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2017-12-11