UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555-0001

July 16, 2003

NRC INFORMATION NOTICE 2003-09: SOURCE POSITIONING ERRORS AND SYSTEM

MALFUNCTIONS DURING ADMINISTRATION OF

INTRAVASCULAR BRACHYTHERAPY

Addressees:

All medical licensees.

Purpose:

The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice (IN) to inform

addressees of four recently reported medical events, with two separate device types, that have

occurred during the conduct of intravascular brachytherapy (IVB) procedures. These medical

events involved errors in positioning the IVB sources or system malfunctions, resulting in

administration of the dose to the wrong treatment site. Two events involved inadequate

understanding of source positioning details for the most recent device being employed. The

third event involved catheter malfunction and inadequate visualization of the active source and

the fourth event involved system malfunction.

It is expected that recipients will review this information for applicability to their licensed

operations and consider actions, as appropriate, to avoid similar problems. However,

suggestions contained in this IN are not new NRC requirements; therefore, no specific action

nor written response is required. 

Description of Circumstances:

NRC has received four recent medical event reports involving administration of IVB doses to

the wrong treatment sites. The events are summarized below.

In the first event, the licensee had been using a Guidant Galileo IVB system and had recently

received an upgraded software system, the Guidant Galileo III. The old system was updated, in

part, to allow delivery of the dose in two parts to the distal and proximal ends of the lesion. The

new system automatically sends out an inactive wire with a marker that should align with a

marker on the catheter placed in the patient. To reach exact alignment, the user may need to

manually “fine tune” the positioning. With the old system, the positioning is accomplished

essentially the same way. On the day of the first use of the upgraded system, the vendor’s

representative arrived on site to provide training. However, the first patient had already been

prepped to undergo the treatment and the formal training for the new version was not delivered

prior to the treatment. During the initial use of the upgraded system, the source delivery unit

sent out the inactive wire to a point where its distal marker stopped in the approximate area of 

ML031830015
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the catheter’s distal marker. Since the users had not received formal training, nor had they

reviewed the training manual, they questioned whether they had to manually “fine tune” the

positioning of the inactive wire to align it with the distal end of the catheter. The vendor’s

representative had not used the upgraded system often and did not fully understand the

importance of the marker alignment, and therefore, assured the users that the position of the

inactive wire was acceptable and that the system would advance the active wire to cover the

desired area without any “fine tuning”. As a result, when the source delivery unit sent out the

active wire, the wire traveled 3 to 6 millimeters short of its intended location. The users retracted

the source, were again assured by the vendor’s representative that the active wire would go to

the desired position, and attempted to treat again. The active source wire was run out a second

time and again did not reach the desired treatment position. Subsequently, the inactive wire

was run out and this time the users manually adjusted it to align with the catheter’s distal

marker, and the treatment was administered.

In the second event, the licensee had been using the Novoste Beta-Cath 5 French IVB system

and had recently received the 3.5 French system. One of the differences between the two units

is the method for locating positional markers. The vendor’s representative was present for the

procedure and had provided training to the licensee’s staff prior to staff performing a patient

treatment with the new unit. However, both the vendor’s representative and the Authorized

User were in the room but not in a position to see the source train positioning in the new

catheter which was inserted by the interventional cardiologist. Following insertion of the active

source train, the interventional cardiologist determined, via fluoroscopy, that the source train

was incorrectly positioned and did not cover the desired treatment site. The source train was

withdrawn after 60 seconds of treatment. The catheter was then correctly positioned and

treatment was given to the proper area of the vessel.

In the third event, during a treatment with a Novoste Beta-Cath 3.5 French IVB system, the

source train did not travel the entire way to the treatment site and was 40 millimeters proximal

to the treatment site. The immediate cause of the event was a small kink in the delivery

catheter which kept the source train from traveling to the correct site, even though the kink was

not substantial enough to affect the flow of the sterile water used to send/retrieve the sources. 

The error was identified the next day during the medical physics quality assurance checks of

the films taken during the treatment. The review revealed that the proximal end of the source

train was hidden inside the guiding catheter and was not properly visualized by fluoroscopy

during source placement. The licensee also noted that the proximal and distal markers of the

source train are the same size and shape and are not distinguishable from each other. 

Therefore, the distal end of the source train was mistaken as the proximal end and the entire

dose was delivered to an area 40 millimeters proximal to the intended treatment site. During

on-site review of the event, NRC inspectors observed the licensee conducting a treatment with

the 3.5 French IVB system. Again, the licensee had to remove the catheter from the patient,

due to kinking of the catheter. As in the earlier treatment, the kinking was not substantial

enough to affect the flow of the sterile water. However, the source train remained stuck in the

catheter, requiring removal of the catheter containing the source train from the patient. The

manufacturer is evaluating the system.
IN 2003-09

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In the fourth event, there was a malfunction of the drive mechanism with a Guidant Galileo III

IVB system. A vendor’s representative was present for the treatment. During the treatment the

inactive source successfully reached the proper position (confirmed visually via fluoroscopy)

and returned. The active source was then advanced into the catheter. The licensee noted that

the source movement light continued to blink well after the anticipated transit time. The

licensee attempted to locate the source position via fluoroscopy; however, the source was not

viewed. The licensee performed surveys that confirmed that the source stopped inside the

patient. The licensee assumed a machine malfunction had occurred and initiated emergency

procedures. The indicator light on the console continued to indicate the source was in transit

even after the licensee confirmed the source was in the patient and not at the treatment site. 

While attempting to return the source to the shielded position, the licensee was unable to

retract the source using the machine interrupt, the system stop button, or the manual

hand-wheel. Therefore, the licensee manually removed the catheter and source from the

patient. After the power cord was removed from the wall receptacle, the source was retracted

back to its shielded position. The device is being evaluated for proper operation by the

manufacturer. In addition, the licensee did not contact the State regulatory authority, as

required.

Discussion:

In two of the four cases, the licensees received new designs for systems they had been using,

and did not fully appreciate any differences in the methods used by the new designs for

positioning the active source trains. In addition, a vendor’s representative was present in both

cases, but in one case, the representative did not fully understand the source positional

differences between systems, and in the other case, the representative could not adequately

view the treatment to verify whether correct positional methods were used.

In another case, two issues resulted in the wrong area being treated. First, the catheter kinked,

restricting the source train from traveling to the intended treatment site. Second, the proximal

and distal markers for the source train are the same size and shape. During fluoroscopy of the

treatment area for source placement verification, the licensee’s staff believed that both the

proximal and distal markers had been visualized. However, only the distal marker had been

visualized.

In the last case, there was complete failure in safety systems when emergency procedures

were implemented. The system appears to have malfunctioned both in its ability to recognize

the location of the active source and its ability to retract the active source wire with emergency

features. Although investigation of this reported event is ongoing, presently available

information suggests that the console touch screen used to control the treatment “froze” and

did not display the touch screen interrupt button. In addition, the licensee did not notify the

regulatory authority of this event. Prompt notification of regulatory authorities is essential for

these types of events to ensure that immediate actions are taken to prevent recurrences of

such medical events by this and other device users.

Licensees performing IVB are expected to review this IN and:

• Assure that vendor training has been provided to all users prior to their actual use of 

new devices or re-designs of devices;
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• Encourage device users to review all of the vendors training documentation and clarify

any concerns with the vendors regarding particular devices prior to using the devices for

patient treatments. If direction provided by the on-site vendor’s representatives is

believed to be in error, licensees are expected to clarify any discrepancies with the

manufacturers prior to use.

• Report all system malfunctions to the vendors; and if required, to the licensing

authorities expeditiously; and

• Consider performing quality assurance checks of the films taken during the treatment to

identify whether correct placements of active sources were achieved.

This IN requires no specific action nor written response. If you have any questions about the

information in this notice, please contact the technical contacts below, or the appropriate

regional office.

/RA/

Charles L. Miller, Director

Division of Industrial and

 Medical Nuclear Safety

Office of Nuclear Material Safety 

 and Safeguards

Technical Contacts: Penny Lanzisera, Region I Thomas K. Thompson, Region I

610-337-5169 610-337-5303

E-mail: pan@nrc.gov E-mail: tkt@nrc.gov

Attachments:

1. List of recently issued NMSS Information Notices

2. List of recently issued NRC Information Notices