MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS INC., ONCOLOGY SYSTEMS UNIVERSAL STUMP APPLICATOR SET; SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED

Model Number GM1011160

Device Problem Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2017

Event Type  Injury  

Event Description

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.

• Brand Name: UNIVERSAL STUMP APPLICATOR SET
• Type of Device: SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS INC., ONCOLOGY SYSTEMS; atlanta GA 30329
• MDR Report Key: 7108626
• MDR Text Key: 94694046
• Report Number: MW5073915
• Device Sequence Number: 1
• Product Code: JAQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GM1011160
• Device Lot Number: R38
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Is the Reporter a Health Professional?: Yes
• 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): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 84