MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS, INC. FLETCHER-SUIT-DELCLOS-STYLE APPLICATOR SET; INTRACAVITARY BRACHYTHERAPY APPLICATOR

Catalog Number AL13030000

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Inflammation (1932); Necrosis (1971); Pain (1994)

Event Date 01/01/2011

Event Type  Injury  

Event Description

The customer reported that a gyn patient has allegedly suffered severe radiation reactions outside the treatment area.The patient was treated with the al13030000-fletcher-suit-delclos-style applicator set (fsd) in conjunction with the (b)(4) reusable transfer guide tubes (rtgt).They stated that they checked the plans and delivery, but "didn't find any problem".The customer stated that the rtgts are in good condition and all measure within 1mm of the nominal length of 121.4 cm (120.0 cm for treatment planning).There is a mark on the rtgt, correlating to the table in the rtgt's instructions for use, that is used to verify the insertion depth of the rtgt in the applicator.This is checked prior to and after treatment by 3 people (physician, nurse and physicist).In addition, the customer indicated that there was no evidence that the applicators had been pushed out of the patient at any point during the treatment.The patient was treated with 3 fractions of 8gy each.The physician has concluded that the suspected treatment error occurred for only on fraction, because the patient had a full response to the radiation, and at this time he assumes there was sufficient target dose to result in disease resolution.

Manufacturer Narrative

Varian brachytherapy personnel conducted an on-site investigation at the customer's facility.The treatment workflow, source positioning, and applicators were all discussed and evaluated.All source positioning was accurate and delivered within the afterloader as specified.From the gathered data, it can be concluded that all of the equipment being used at the hospital is within specifications and operating as expected.The on-site visit identified possible treatment workflow contributing factors but no conclusions could be verified.

• Brand Name: FLETCHER-SUIT-DELCLOS-STYLE APPLICATOR SET
• Type of Device: INTRACAVITARY BRACHYTHERAPY APPLICATOR
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS, INC.; 3100 hansen way; palo alto CA 94304
• Manufacturer (Section G): VARIAN MEDICAL SYSTEMS UK LTD.; crawley, west sussex ; UK
• Manufacturer Contact: mark kattman ; 700 harris street; suite 109; charlottesville, VA 22903 ; 4349518632
• MDR Report Key: 3627993
• MDR Text Key: 16086797
• Report Number: 8020711-2014-00001
• Device Sequence Number: 1
• Product Code: JAQ
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K120731
• 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: 01/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AL13030000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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