Summary of MedSun Reports Describing Adverse Events With Brachytherapy Catheters
MedSun: Newsletter #43, December 2009

Brachytherapy catheters are used to introduce radioactive seeds into cancerous tissue. The seeds are then withdrawn after a predetermined exposure time. They may be used with an automated "after loader" device which contains, loads, and withdraws the seeds as programmed by the user.
Source: American Brachytherapy Society, "About Brachytherapy." Online Available at: http://www.americanbrachytherapy.org/aboutBrachytherapy/history.cfm.
Over the past 2 years, MedSun has received 12 adverse event reports associated with the brachytherapy catheter device manufactured by multiple firms. These manufacturers include Cytyc Surgical Services, Inc., Cianna Medical, Inc., SenoRx, Inc., Best Medical International, Inc., Best Vascular, Inc. and Terumo Medical Corporation. The reports were submitted by 8 hospitals. The most frequently reported device problems were:
• Catheter balloon rupture/leaking (5)
• Catheter tip breaking off in patient (2)
• Catheter had a kink/bent (2)
• Catheter balloon became filled with blood (2)
• Catheter balloon would not deflate/inflate properly (1)

There were no reports involving a patient death. The patient injuries listed below were reported in 4 of these 12 reports.
• Balloon contents mixed with patient biological fluids (2)
• Catheter tip needed removal from patient (2)

Of the reports that listed patient age, 7 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 11 reports involved female patients and 1 report involved a male patient. These MedSun reports contributed to FDA awareness of the device problems.

[Note: The reports have been edited for clarity]

Adverse Event Table
ManufacturerDevice Device Identifier Description
Terumo Medical Corporation Brachytherapy Glide Catheter Catalog #:CG415; Device Lot #:081212 During a popliteal percutaneous angioplasty with brachytherapy, a piece of the glide catheter broke off in the patient's left femoral artery. A guide wire was in the left femoral artery and a 65cm glide catheter was inserted over the wire. When the physician tried to remove the glide catheter over the wire the glide catheter hung up and became difficult to remove. The glide catheter broke off inside the patient. The surgeon had to perform a cutdown to obtain the foreign body and proceeded with original procedure
Best Vascular, Inc. ICRT catheter Unknown Novoste BetaCath System: the ICRT catheter was kinked so the Sr-90 radioactive train could not be sent back to the device. After the treatment was finished, MD tied to push the Sr-90 radioactive source back to the device, the source left the treatment area and was stuck in the catheter junction outside of the patient's body. MD said the catheter had a kink at the junction. The catheter was pulled out from the patient's body and dumped in a shielded transportation box with whole device. The patient and room was surveyed using radiation survey meter. No radiation was found inside the patient body and in the treatment room of the cardiac cath lab.
Cytyc Surgical Services, Inc MammoSite balloon catheter Device catalog #:2456; Device lot #:08F24HB Patient in OR for re-excision of a right breast lumpectomy. When breast opened, noted MammoSite balloon catheter was ruptured
Best Medical International, Inc. Intravascular Brachytherapy (IVB) source Device model #:SR-90 The patient was being treated with an Intravascular Brachytherapy (IVB) source. Upon completion of the treatment, the source would not retract out of the patient and into the source housing. Emergency procedures were done to attempt to take the device out. The final procedure was to pull the entire IVB and catheter system out of the patient which was done. The system was placed in the emergency box and the IVB was put in a hot lab for storage. The source will be sent back to the vendor for analysis. No obvious injury to patient.
SenoRX, Inc. Brachytherapy Catheter Device lot #:M08091606 The patient had a left axillary sentinel node biopsy and left wire-localized partial mastectomy with complex closure greater than 3mm. Before the cavity was closed, the Mammosite cavity evaluation device was placed into the cavity, instilled with 35ml of saline and US was performed. The ultrasound demonstrated a balloon to skin thickness medial to the incision of 65mm, inferolateral to the incision 50mm and superolateral to the incision 75mm. The balloon was deflated and removed. Subsequently, approximately three weeks post-mastectomy, the patient had placement of a Contura brachytherapy balloon in the left breast at the 2 - o'clock position with no complications. A simulation note, four days later, states that the balloon had been filled with 30ml of saline and 1ml of contrast to help with imaging. 3mm axial slices were taken of the breast. The images were sent to the treatment planning system and evaluated. It was apparent that the seroma in the superior position of the breast superior to the Contura balloon remained intact with very little resolution. Evaluation of the lumpectomy cavity was that it was too far distant from the surface of the Contura balloon due to the seroma. It was determined that she was not a candidate for partial breast radiation using that balloon. The balloon was pulled 5 days after initial placement, and the fluid extracted from the balloon was bloody and cloudy. The catheter was found to not be appropriate for the intended therapy and therefore was discontinued. The fluid in the balloon was found to be bloody and cloudy. Documentation indicates that 1 ml of contrast had been added to the 30 ml of saline which accounts for the cloudiness but not the bloody appearance.
SenoRx, Inc. Balloon Catheter Other device #:B011-45 The balloon applicator had blood in the radiation ports. This is not appropriate since it can contaminate the high dose rate brachytherapy device which is used on multiple patients at a time. The manufacturer's representative was present. This is a known manufacturing error that has occurred in 2 out of 1000 cases. The balloon was pulled and replaced with a different type of device.
Cytyc Surgical Services, Inc. Mammosite Balloon Catheter Device lot #:07F20H Patient had Mammosite CT planning. When patient returned the next day for first treatment, she stated the balloon had burst. She did call her physician's office that night and they stated that was probably what happened. We then took her into the HDR (High Dose Radiation) suite and verified it with a C-Arm
Cytyc Surgical Services, Inc. Mammosite Balloon Unknown Patient reported to us that she heard a popping noise the day before; she thought the mammosite balloon had burst. We did a CT scan and this confirmed that the balloon had burst. New catheter was put in.
Cytyc Surgical Services, Inc. Mammosite Balloon Device lot #:06E09 Two mammosite balloon catheters placed were defective. First placement burst in the night; second placement, three days later deemed to be asymmetrical upon evaluation in Radiation Oncology and had to be removed.
Nucletron Source Position Simulator Part #:111.094 The patient had been simulated for high dose partial breast radiation of short duration. When the patient returned for her second treatment, the catheter measurements, measured by Nucletron source position simulator, were different than for the first treatment. Investigation showed an obstruction or kink in the Source Position Simulator, and an error in the measurement of length during the initial treatment where the radioactive source should reside within applicator system. The remaining dose was adjusted, and the patient was not injured.
Cianna Medical, Inc. SAVI Catheter Unknown Image guided placement of a partial breast radiation brachy catheter device was planned. The cavity was measured at 5.87cm x 2.32cm and was somewhat irregularly shaped, but the seroma cavity was well visualized. A laparoscopic trocar device was used to dilate the tract and a SAVI 8.1 breast applicator device was inserted under direct vision. When the struts were deployed there was quite a bit of resistance met. The catheter was removed and inspected. The catheter had deformed from the scar tissue within the cavity since the cavity was approximately 8 weeks old at the time. A balloon applicator was filled with 30ml of sterile saline and used to dilate the seroma cavity. The catheter was allowed to dwell in the seroma for several minutes and the saline was evacuated. A fresh Savi 8.1 device was then applied. The new catheter was applied under US guidance into the seroma cavity. It went in easily and seemed to deploy well. The applicator was turned four complete revolutions to partially deploy the device. Placement was verified using US in a transverse orientation and the struts were partially deployed as expected. The following day the patient was called back for additional CT simulations with treatment planning. Based on the CT imaging, the catheter was expanded when it was determined that it was not fully expanded originally. No problem were reported with that expansion. However, they did see that multiple struts were inverted which required a recommendation to remove the device. The doctor attempted to take the struts down but the catheter was completely jammed and the apparatus was not functioning properly. The SAVI physicist was present and witnessed that the device did not deflate properly. The doctor did remove the device at that time when it was determined that it would slide out, rather than take the patient to surgery. The patient was medicated with morphine and the area was closed with steri-strips. A small area of ecchymosis developed at the site but there was no sign of infection. This event was reviewed by radiation physicists at this facility who stated: it is possible that the time period between the lumpectomy and the catheter implant may have exceeded the recommended time limit. It was noted that identification of the catheters on CT was difficult because some were inverted. The catheter inversions may have been caused by the fibrotic cavity. The cavity was contoured on Pinnacle and the estimated volume was 91.5 cc which exceeds the recommended limit (90.0cc)of the largest (10-1) SAVI implant and this was communicated to the manufacturer. The manufacturer told the medical providers at our facility that, among other things, the cavity may shrink so this was not a concern. It had been 8 weeks since the lumpectomy was performed, at the time the catheter was placed, which exceeded the 6 week recommended limit. Two manufacturer's reps were present and assisted during the implant. The day after the implant the patient was scanned and the images were transferred first to Pinnacle and then to Brachyvision for planning. A physician from Cianna was present to assist. This was our facility's first SAVI case. CT images showed the inverted catheter struts, probably caused by the length of time between surgery and insertion of the catheter. Attempts were made to make sure the device was fully expanded and a rep from Cianna was present to help with that. Rescanning showed that the struts were clustered and couls not be individually identified. Another rep from Cianna informed the providers that the case couls not be planned and the catheter was to be removed. The expansion tool was rotated by the doctor to collapse the implant and external inspection and lack of resistance gave the appearance that it had collapsed. The implant was pulled out, but following inspection after removal, it was clear that it had not collapsed. The catheter was given to the manufacturer's rep. No packaging was kept by the hospital, and no identifying information was recorded.
Cytyc Surgical Services, Inc. MammoSite Balloon Device model #:2056; Device lot #:07F20H A spherical MammoSite balloon was being inserted under ultrasound blood guidance into the right breast. The balloon was placed and then saline was infused. During the infusion, the balloon began to leak and saline spilled out. The balloon was removed and a second one was placed. There was no harm to the patient as a result of this incident.





Recall Table
Recall NumberDevice Manufacturer Recall Class Reason for Recall
Z-1020-2009 TheraSeed Spacers Theragenics Corporation 2 Some pouches were found to have weak seals potentially compromising sterility.
Z-0921-05 Flexible Implant Tube; part # GM11003730 Varian Medical Systems 2 A defective treatment applicator in a cancer therapy medical device may become separated potentially causing patient injury.



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