MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS, INC. BRACHYVISION; SYSTEM, PLANNING, RADIATION THERAPY

Lot Number V.11.0.41

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Reaction (2414)

Event Date 03/25/2014

Event Type  Injury  

Event Description

Two patients were treated for prostate cancer with hdr brachytherapy.Several weeks after treatment, the physician observed a strong skin reaction to the perineum for both patients.Patient #1 was treated on (b)(6) 2014.The physicists measured the applicator length (needle + transfer guide tube (part numbers pending)) to be 136cm.The default brachyvision applicator length of 130cm was not edited by the customer to equal 136cm prior to treatment.The result was delivery of all of the dwell positions 6 cm inferior to the intended locations.Details regarding patient #1 reported under mfr report #3003793371-2014-00001.

Manufacturer Narrative

A varian field service engineer went to the clinic and made tests on the after loader regarding source positioning and checked the event logs (no fault event on related treatment dates).All of the tests showed that there was no fault with the after loader itself.The field service engineer and the physicist then reproduced the treatment using the same plan used for one of the affected patients and found an off-set of approximately 6 cm in respect to the intended target position.The original training was delivered more than 14 years ago to one of the physicists at the site.That particular physicist left the site a few years later.Additional training was conducted by varian personnel in 2013, with the a different physicist who did not participate in the original training.Last month, that physicist left the site and a new physicist was hired.The remaining 2 physicists have never been on a varian training.They have treated 5 patients since the physicist, who had been trained by varian, left on (b)(6) (3 gyn and 2 prostate patients).For the gyn patients, they changed the distance to 120 cm (in brachyvision), which is the measured applicator length.For the prostate patients they measured about 136 cm for the applicator length and did not change the length on the brachyvision plan to match.It is the conclusion of this investigation that the primary and root cause of this issue is user error.

• Brand Name: BRACHYVISION
• Type of Device: SYSTEM, PLANNING, RADIATION THERAPY
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS, INC.; 3100 hansen way; palo alto CA 94304
• Manufacturer (Section G): VARIAN MEDICAL SYSTEMS FINLAND OY; helsinki ; FI
• Manufacturer Contact: mark kattmann ; 501 locust avenue; suite 1; charlottesville, VA 22902 ; 4349518632
• MDR Report Key: 3854893
• MDR Text Key: 4621568
• Report Number: 3003793371-2014-00002
• Device Sequence Number: 1
• Product Code: MUJ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K102011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/02/2014

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 Lot Number: V.11.0.41
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2014
• Initial Date FDA Received: 05/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other