MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS BEACON CARE PACKAGE

Model Number ASM0094-002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 05/13/2015

Event Type  Injury  

Event Description

The patient had beacon transponders implanted transrectally.The patient received prophylactic treatment with cipro and gentamicin.The physician reported that the patient developed an infection and required daily outpatient antibiotic injections.The site performs 15-20 transponder implantations per month and have experienced an infection rate of approximately 1 of every 50 patients.The site reported the infections to varian for further investigation since three patient infections in three weeks was statistically higher than usual.As of today, the site claims to have implanted twenty additional patients and none have experienced infections.

Manufacturer Narrative

Product investigation: the beacon care package lot history record was reviewed and found to be acceptable.The lots was sterilized within the validated range of 25 to 40 kgy.A review of the sterilization validation dose and environmental monitoring was also found to be acceptable.A review of the complaint database shows no other complaints regarding implantation infections.The instructions for use (ifu) states that infections (e.G.Urinary tract infection) are a known adverse reaction.The ifu suggests the use of antibiotic prophylaxis prior to fiducial implantation, followed by standard practice of patient care.Event investigation: discussions were held with the medical director at uro partners, dr.Mehta.He indicated that cipro and gentamicin were prescribed as the antibiotics for prostate implant patients.The site had no infections for about 5 months, then had 3 infections within 3 weeks without obvious cause.The occurence of three infections seemed unusual to them.As part of investigating all possible causes including their own procedures, they contacted varian.Since the reported infections, uro partners claims to have implanted 20 additional patients and none have experienced infections.Based on the prior favorable experience and the current favorable experience conveyed by dr.Mehta, this is a simple variation in clinical outcomes.(b)(4).

• Brand Name: BEACON CARE PACKAGE
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS; seattle WA
• Manufacturer Contact: jeff semone ; 2101 fourth ave; suite 500; seattle, WA 98121 ; 6504246833
• MDR Report Key: 4846667
• MDR Text Key: 5873986
• Report Number: 3004837948-2015-00003
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2016
• Device Model Number: ASM0094-002
• Device Catalogue Number: ASM0094-002
• Device Lot Number: 00015363/00015865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR