MAUDE Adverse Event Report: BRAINLAB AG EXACTRAC PATIENT POSITIONING SYSTEM VERSION 6.2; RADIOLOGICAL WHOLE-BODY POSITIONER

Model Number 20882-01L

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2022

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since a radiation treatment dose was delivered to a different location in the brain than intended with the brainlab exactrac patient positioning system involved, despite according to the radiation oncologist and medical physicist (treating clinicians): - the deviation of the treatment target position for 5 of the 10 beams was detected during the radiation treatment, and the irradiation of the 5 deviating beams was repeated on the same day to the correct target.- there was no harm or negative effect to the patient, no organs at risk received any dose by the deviation, and there was no (direct or increased) risk to harm a critical structure due to this dose deviation.- the final outcome of this radiation treatment was effective as intended, as good as planned.- there were further no remedial actions necessary, done or planned for this patient.There was no prolong of hospitalization either.\ according to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the root cause for the deviation of the patient from the planned treatment position by approximately 2cm in all spatial directions, is: - deviations in the image fusion between the x-ray images acquired and the rendered drrs (obtained from a pre-treatment ct scan containing the planned target) that were not detected by the user - neither at the required review for initial patient position correction, nor at the subsequent two x-ray position verifications - prior to providing treatment authorization.The deviating image fusion most likely happened due to a region of interest defined by the user for this fusion that did not include sufficient unique anatomical landmarks.The exactrac positioning software displayed warnings to the user during initial x-ray correction and the x-ray verifications that the fusion result shall be reviewed.In addition, the fusions were not approved by the user - the log files provided from this treatment show that the positioning for treatment continued without user approval of the fusion after the "fusion not approved" warnings by the exactrac sw.There is no indication of a systematic error or malfunction of the brainlab device (exactrac patient positioning system).Corresponding brainlab measures to minimize this anticipated risk as low as reasonably practicable are already in place.Brainlab intends to re-iterate the relevant topics regarding the use of the device to this customer.

Event Description

A single fraction cranial radiation treatment for a palliative radiosurgery of a brain metastasis located front parietal ca.7cm deep with a size of ca.4ccm, from small cell neuroendocrine lung cancer, with intended 10 static beams of 2x2cm delivering 18gy, has been performed at a linear accelerator using the brainlab exactrac patient positioning system version 6.2.During the radiation treatment the therapists: - placed the patient on the couch of the non-brainlab linear accelerator (linac).- opened the positioning plan imported into exactrac.- first for the 5 beams at couch angle 0°, acquired x-rays with exactrac and fused these to the digitally reconstructed radiographs (drrs) calculated by exactrac from a pre-treatment ct scan containing the planned target.- applied the calculated couch shift from exactrac to position the planned target in the patient into the isocenter of the linac.- acquired verification x-rays of the current treatment position, fused these again to the drrs, and applied a further small position correction calculated by exactrac to the linac couch with the patient on it.- repeated the x-ray verification with exactrac, and authorized the radiation treatment.- when moving to a different couch angle for the remaining beams and applying the exactrac positioning, detected that there was a high position deviation to correct.Subsequently, a position and target deviation by ca.2cm in all spatial directions of the first 5 beams at couch angle 0° was determined.The radiation oncologist decided to repeat the irradiation of the 5 deviating beams to the correct target, to complete the radiation treatment effective as intended on the same day.According to the radiation oncologist and medical physicist (treating clinicians): - the deviation of the treatment target position for 5 of the 10 beams was detected during the radiation treatment, and the irradiation of the 5 deviating beams was repeated on the same day to the correct target.- there was no harm or negative effect to the patient, no organs at risk received any dose by the deviation, and there was no (direct or increased) risk to harm a critical structure due to this dose deviation.- the final outcome of this radiation treatment was effective as intended, as good as planned.- there were further no remedial actions necessary, done or planned for this patient.There was no prolong of hospitalization either.

• Brand Name: EXACTRAC PATIENT POSITIONING SYSTEM VERSION 6.2
• Type of Device: RADIOLOGICAL WHOLE-BODY POSITIONER
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer Contact: markus hofmann ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 15281318
• MDR Text Key: 298580789
• Report Number: 8043933-2022-00049
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 04056481000264
• UDI-Public: 04056481000264
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K120789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20882-01L
• Device Catalogue Number: 48364
• Device Lot Number: SW V. 6.2.4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2022
• 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