MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION SYSTEM - NAVIGATION 4.0; IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 26615-01B

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

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

Event Date 05/20/2022

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since instrument paths and biopsies were applied in a different location in the brain than anticipated, with the brainlab device involved, despite according to the surgeon: there was no actual harm or negative clinical effect to the patient due to the biopsy, nor was there any direct (or increased) risk of harm to a critical structure due to the biopsy.There were no further medical/surgical remedial actions necessary, done, or planned for this patient at this time.Hospitalization was not prolonged either.It is not known at this time whether the outcome of the surgery was successful, or whether a revision surgery will be required - the collected tissue samples are still undergoing pathological analysis.According to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the root cause of the navigated biopsy trajectory applied deviating by ca.8mm was due to an insufficient distribution of points acquired by the user for patient anatomy registration to navigation, not following brainlab requirements.Specifically, not many surface matching points were taken at unique bony landmarks e.G.Around the eyes and entire profile of the nose.This caused the navigation software to not find an as accurate match as desired in the region of interest for this specific procedure, between the preoperative image dataset and actual patient anatomy.As a potential minor contributing factor - a shift of the patient's brain anatomy during surgery (as seen on the post-operative scan), when compared to the pre-operative scan used with navigation, due to e.G.The burr hole and/or loss of cerebrospinal fluid.The shift of the patient's brain cannot be recognized or compensated by the navigation system, which uses the pre-operative image data for display of instrument positions relative to the patient anatomy.Apparently the resulting deviation of the navigation display was not recognized by the user with the required thorough verification of navigation prior to accepting the registration, after draping, and throughout the procedure (prior to making the incision and burr hole).There is no indication of a systematic error or malfunction of the brainlab device (navigation).Corresponding brainlab measures to minimize this anticipated risk as low as reasonably practicable are already in place.Brainlab intends to reiterate the relevant topics regarding the use of the device to this customer.

Event Description

A cranial surgery for a diagnostic biopsy of a brain tumor approximately 5cm in diameter and at a depth of 7cm, was performed with the aid of the display by the brainlab cranial navigation software 4.0.A pre-operative mri and ct were acquired nine and seven days prior to the surgery, respectively, for use with navigation.The surgeon also preoperatively planned a trajectory for the biopsy in the brainlab software and fused (aligned) the ct and mri for use with navigation.During the procedure the surgeon: positioned the patient supine in a non-brainlab headholder and attached the navigation reference array.Performed the initial patient registration on the pre-op ct acquiring registration points on the patient's skin to match the display of the navigation to the current patient anatomy.Verified the accuracy of the registration and accepted it to proceed.Used the navigated pointer to mark the entry point on the patient's skin and draped the patient.Made a skin incision and created the burr hole in the location of the previously marked entry point.Calibrated a non-brainlab biopsy needle to the navigation and accepted the accuracy of the calibration to proceed.Attached a non-brainlab biopsy needle holder to the bone over the burr hole, opened the dura, and inserted the navigated needle down the planned trajectory path.Collected eight tissue samples at the target location, and completed the surgery.The samples were sent for analysis by pathology.A post-operative scan was performed and it was determined that the location of the actual biopsy deviated from the planned location by 8mm laterally (target and entry).According to the surgeon, the pathology results are not available yet (at this time of writing).According to the surgeon: there was no actual harm or negative clinical effect to the patient due to the biopsy, nor was there any direct (or increased) risk of harm to a critical structure due to the biopsy.There were no further medical/surgical remedial actions necessary, done, or planned for this patient at this time.Hospitalization was not prolonged either.It is not known at this time whether the outcome of the surgery was successful, or whether a revision surgery will be required - the collected tissue samples are still undergoing pathological analysis.

• Brand Name: CRANIAL NAVIGATION SYSTEM - NAVIGATION 4.0
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• 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: maura pascarella ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 14760104
• MDR Text Key: 294932176
• Report Number: 8043933-2022-00037
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481141356
• UDI-Public: 04056481141356
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K192703
• 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: Physician
• Type of Report: Initial
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 26615-01B
• Device Catalogue Number: 26615-01B
• Device Lot Number: SW V. 4.0.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• 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