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 Intracranial Hemorrhage (1891)

Event Date 10/05/2023

Event Type  Injury  

Manufacturer Narrative

B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since burr hole and biopsy path was performed in another location than intended with the brainlab device involved, although/and: - the purpose of this surgery was to only receive a diagnostic sample and not to remove the lesion and/or treat the disease - a deviation between planned and actual trajectory was detected in the post-op mri (about 2.5mm for the burr hole, about 3mm for the cortical vein that was injured) - the outcome of this specific surgery was not successful as intended (one pass with four samples was intended, no tissue sample was obtained) - there was a risk of harm to a critical structure: a hemorrhage occurred (injury to the cortical vein), which required immediate surgical intervention (thrombin injected into the biopsy syringe) to avoid/revert permanent damage to the patient - there was no actual harm to the patient due to the deviating biopsy path and bleeding - there was no prolongation of surgery/anesthesia time, however, hospitalization was prolonged by approx.4 days due to the need of a revision surgery - the revision surgery (open biopsy) was performed on (b)(6)2023 successfully, the desired diagnostic sample was obtained; aid of navigation was used, but not same brainlab equipment from the original case; the original burr hole was used by creating a craniotomy near the site of the original burr hole using a non-navigated non-brainlab drill; the surgery/anesthesia time was 2.5 hours, and there were no negative clinical effect to the patient as a result of the repeat surgery/anesthesia - no further remedial actions were reported that would have been necessary, done or planned for this patient as a result of the deviating biopsy path and bleeding (besides revision surgery) 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 and biopsy path performed with the aid of navigation deviating by ca.2.5-3mm from their intended location (which is within the expectable system accuracy of 3mm) is: - a non-recommended scan (skin shift due to "flattened"/supine position of the patient's head during the scan) limited the ability to collect registration points per recommendations (at the rear of the patient's head and around the region of interest).The suboptimal point acquisition caused the navigation to not find an as accurate match in the region of interest as desired for this specific procedure in between the preoperative image dataset and actual patient anatomy.In this case, additional points could have been collected along the left side of the patients nose (unique anatomical structure) and in areas without skin shift closer to the region of interest based on the data received (3d reconstruction), to improve the registration result.Apparently, the resulting deviation between the actual anatomy location during the surgery and the registered pre-operative 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 before applying significant invasive surgical actions.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.

Event Description

A cranial surgery for diagnostic biopsy of a lesion located right parietal at a depth of approx.19.2 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).A pre-operative mri was acquired at the day of surgery for use with navigation, 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 - performed the patient registration on the pre-operative mri scan by acquiring surface matching registration points with the brainlab softouch and z-touch registration pointer on the patient head's skin, to match the display of the navigation to the current patient anatomy, verified the registration to navigation, and accepted the accuracy to proceed - performed a lumbar puncture - located the planned trajectory with the softouch and marked the entry point on the patient's skin, draped the patient, and exchanged the unsterile navigation reference for a sterile one - attached the brainlab varioguide and aligned it to the planned trajectory - made the skin incision through the varioguide using a long thin non-brainlab handle - inserted the brainlab drill guide into the varioguide, and created a burr hole (craniotomy) of 3.2 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, first only till dura to verify burr hole depth (that they reached dura), then further to the target - while doing so, noticed excess bleeding, and added thrombin down the biopsy needle to stop the bleeding - after the bleeding had stopped, decided not to continue with the biopsy due to the bleeding, and to await if the lumbar puncture yields a diagnosis according to the hospital/neurosurgeon: - the purpose of this surgery was to only receive a diagnostic sample and not to remove the lesion and/or treat the disease - a deviation between planned and actual trajectory was detected in the post-op mri (about 2.5mm for the burr hole, about 3mm for the cortical vein that was injured) - the outcome of this specific surgery was not successful as intended (one pass with four samples was intended, no tissue sample was obtained) - there was a risk of harm to a critical structure: a hemorrhage occurred (injury to the cortical vein), which required immediate surgical intervention (thrombin injected into the biopsy syringe) to avoid/revert permanent damage to the patient - there was no actual harm to the patient due to the deviating biopsy path and bleeding - there was no prolongation of surgery/anesthesia time, however, hospitalization was prolonged by approx.4 days due to the need of a revision surgery - the revision surgery (open biopsy) was performed on (b)(6) 2023 successfully, the desired diagnostic sample was obtained; aid of navigation was used, but not same brainlab equipment from the original case; the original burr hole was used by creating a craniotomy near the site of the original burr hole using a non-navigated non-brainlab drill; the surgery/anesthesia time was 2.5 hours, and there were no negative clinical effect to the patient as a result of the repeat surgery/anesthesia - no further remedial actions were reported that would have been necessary, done or planned for this patient as a result of the deviating biopsy path and bleeding (besides revision surgery).

• 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: 18002099
• MDR Text Key: 326454920
• Report Number: 8043933-2023-00069
• 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: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• 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: 10/05/2023
• 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): Required Intervention; Hospitalization