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

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 11/06/2023

Event Type  Injury  

Event Description

A cranial surgery for a laser interstitial thermal therapy (litt) for ablation of a tumor, about 5 cm in size and located right temporal at a depth of approx.180 mm in the brain, has been performed with the aid of the brainlab nav.Sw cranial 4.0.0 (and the brainlab nav.Sw cranial 3.1.5 with varioguide) (on (b)(6) 2023).Placement of one laser fiber was intended, with a biopsy of the tumor beforehand with the same path.Pre-operative mri scans were acquired five days before the surgery, and a trajectory was planned.During the procedure the surgeon: - positioned the patient in a lateral orientation in a non-brainlab head holder, with the head turned to the patient's left, and attached the reference array for navigation to the head holder.- turned the patient 90 degrees according to where the ct scanner was positioned, acquired an intra-operative ct scan of the patient's region of interest with automatic image registration of the current patient anatomy to the navigation, verified registration accuracy, and accepted the accuracy to proceed, verified and confirmed registration accuracy also on the fused pre-operatively acquired mri scan.- turned the patient another 90 degrees so that the surgeon had enough space to operate on the patient, verified registration accuracy again on the mri scan and determined it accurate.- located the planned trajectory with aid of navigation, marked the entry point on the patient's skin, reviewed it again and slightly edited the planned trajectory's entry point, re-marked it on the patient's skin.- draped the patient and exchanged the unsterile navigation reference for a sterile one.- aligned the varioguide to the planned trajectory and verified that it was in line with the marked entry point.- made the incision through the varioguide using a long thin non-brainlab handle.- inserted the non-brainlab drill guide into the varioguide, and created a burr hole (craniotomy) of 4.5 mm by drilling through the drill guide within the varioguide.- switched out the drill guide within the varioguide for the brainlab device guide (to be used with the navigated brainlab-distributed biopsy needle).- inserted the biopsy needle through the device guide to the dura to verify that they had reached the dura, switched back to the drill guide and used the dura piercer, switched back to the device guide and inserted the biopsy needle through the device guide to the target.- acquired an intra-operative verification ct scan of the patient's region of interest with automatic image registration, and detected a deviation of the biopsy needle location from the intended position (2 mm at the entry point and about 3 mm closer to the target).- decided to still proceed in this location and took biopsy samples.- removed the biopsy needle and device guide and placed a non-brainab bolt inserter through the varioguide, and placed a non-brainlab bolt into the burr hole.- moved the varioguide out of the way, inserted the laser fiber through the bolt, and proceeded with the thermal laser treatment.According to the hospital/neurosurgeon: - the deviation of the biopsy needle placed with the aid of navigation was detected by the surgeon with an intra-operative ct scan before taking tissue samples, placing the laser fiber and administering the thermal laser treatment in the brain; there was no correction/extension of the burr hole needed nor a correction of the trajectory.- the final outcome of this surgery was considered successful as intended, despite the desired (pathological) samples were not obtained, and not the entire structure was ablated.- there was no direct (or increased) risk of harm to a critical structure (blood vessels).- there was no actual harm/negative clinical effect to the patient due to the deviating biopsy and laser fiber placement, there was also no prolonged surgery/anesthesia time.- there were no further remedial actions necessary, done or planned for this patient, nor did the patient require prolonged hospitalization.

Manufacturer Narrative

B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since a burr hole, biopsy path, and bolt placement were performed in a different location in the brain than anticipated and planned with the brainlab navigation involved, despite according to the surgeon: - the deviation of the biopsy needle placed with the aid of navigation was detected by the surgeon with an intra-operative ct scan before taking tissue samples, placing the laser fiber and administering the thermal laser treatment in the brain; there was no correction/extension of the burr hole needed nor a correction of the trajectory.- the final outcome of this surgery was considered successful as intended, despite the desired (pathological) samples were not obtained, and not the entire structure was ablated.- there was no direct (or increased) risk of harm to a critical structure (blood vessels).- there was no actual harm/negative clinical effect to the patient due to the deviating biopsy and laser fiber placement, there was also no prolonged surgery/anesthesia time.- there were no further remedial actions necessary, done or planned for this patient, nor did the patient require prolonged hospitalization.H6: according to the results of the technical investigation and the information provided by the hospital, it can be concluded that the most likely root cause of the burr hole, biopsy path, and bolt placement performed with the aid of navigation deviating by ca.2-3mm from their intended location (which is within the expectable system accuracy of 3mm for the used brainlab nav.Sw cranial, and 5mm for its use with varioguide) is: - a movement of the navigation reference array due to a non-rigid fixation and/or inadvertent forces applied after patient registration was performed.Comparison of the array position as shown in the intra-operative ct scans confirmed that the array had moved after patient registration, and before burr hole creation and biopsy needle/bolt placement.A position change of the reference array after patient registration disrupts the coordinate system established at registration, and causes a deviation between the locations of the patient image scan displayed by the navigation and the actual patient anatomy during surgery.Apparently, the resulting deviation between the actual anatomy location during the surgery and the registered patient image scan displayed by the navigation was not recognized by the user with the required thorough verification of the registration accuracy, nor with the necessary continued verification of navigation accuracy after draping and throughout the procedure, including burr hole creation and biopsy needle placement.The second intra-operative ct scan revealed the reported deviation after biopsy needle placement and the user decided to continue with navigation without biopsy path adjustment.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.H7: brainlab intends to re-iterate the relevant topics regarding the use of the device to this customer.

• Brand Name: CRANIAL NAVIGATION SYSTEM 4.0
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC, PRODUCT CODE: HAW
• 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: andrea miller ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 18208179
• MDR Text Key: 328959124
• Report Number: 8043933-2023-00080
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481141356
• UDI-Public: 04056481141356
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• 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: 26650B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other