MAUDE Adverse Event Report: BRAINLAB AG NAVIGATION SOFTWARE CRANIAL EM (VERSION 1.1); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 22240-06B

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 11/23/2020

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since catheters and rns leads were applied in a different location in the brain than anticipated, with the brainlab device involved, despite according to the surgeon: the misplaced leads were detected during the surgery and were replaced successfully at the very same surgery using the aid of optical navigation.The outcome of the surgery was successful as intended; the leads were placed successfully to the intended locations.There was no direct (or increased) risk of harm to any critical structure (e.G.Brain tissue/structure, blood vessels, etc.) due to the reported problem.There was no actual harm or negative clinical effect to the patient due to the reported problem, nor due to the prolonged anesthesia of 30-60 min.There are no further medical or surgical remedial actions necessary, done, or planned for this patient.Hospitalization was not prolonged 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 display of navigation compared to the actual patient's anatomy, leading to misplacements of two rns leads can be attributed to a combination of the following factors: movement of the em patient reference on the patient's skin relative to patient anatomy due to inadvertent forces applied during the user's patient preparation after registration to navigation, e.G.Via pulling forces by the reference's cable when fixed without sufficient strain relief, and not following the brainlab recommendations as required when using the em patient reference to only perform patient registration in the sterile environment after the draping procedure has been completed.A less than optimal mri scan used for registration to navigation and an insufficient point acquisition by the user during patient registration, not following the recommendations as required, which caused the em cranial 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 the actual patient anatomy.Specifically, the mri scan was acquired approximately 4 months before the date of procedure and included headphones which likely introduced skin shift and may have negatively impacted the registration result especially since points were acquired in that area.In addition, the point acquisition by the user was not as required for the navigation, with points not sufficiently distributed on unique bony areas (e.G.Down to the tip and sides of the nose) and on both sides of the patient's face and head as necessary.Apparently the resulting deviation of the navigation display was not recognized by the user with the necessary continued verification of accuracy after draping and throughout the procedure (prior to the determination of the burr hole location, and to the corresponding catheter placements).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 placement of three leads for a responsive neurostimulation (rns) system, was performed with the aid of the display by the brainlab navigation software cranial em 1.1.A preoperative mri scan was acquired approximately four months prior to the surgery, to use with the electromagnetic (em) navigation.Three trajectories were planned on the mri scan pre-operatively in the navigation software.During the procedure the surgeon: positioned the patient in supine position with lateral head tilt to the right, placing the patient's head on a horseshoe head holder.Secured the patient reference to the patient's head with tape.Performed the initial patient registration on the preoperative mri using the em registration pointer 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 the registration to proceed.Draped the patient, exposed the skull, and verified accuracy of the navigation.Determined the three burr hole placements using the aid of navigation based on the entry points of the pre-planned trajectories, and created the burr holes using a non-navigated drill.Used the navigated em stylet to place catheters following the planned trajectories.The catheters were used to place two rns leads.Verified accuracy of the navigation with the em stylet and detected a deviation of approximately 5mm of the display of the em stylet in the navigation software which appeared superficial compared to its actual position, when tracing it along the patient's skull.Attempted a re-registration under the sterile drapes but was unable to achieve an acceptable result, and decided to use a different (optical) brainlab navigation software instead.The patient was closed, the sterile drapes were removed, and an acceptable patient registration was achieved using the optical brainlab navigation software.Continuing the surgery and using the aid of the display of the optical navigation software, it was determined the burr hole locations (and entry points of the leads) had not been made in the planned and intended locations, and thus the surgeon did not have confidence in the placements of the two rns leads.The surgeon removed the two leads and used the aid of the optical brainlab navigation software to successfully place all three planned leads to their intended locations.According to the surgeon: the misplaced leads were detected during the surgery and were replaced successfully at the very same surgery using the aid of optical navigation.The outcome of the surgery was successful as intended; the leads were placed successfully to the intended locations.There was no direct (or increased) risk of harm to any critical structure (e.G.Brain tissue/structure, blood vessels, etc.) due to the reported problem.There was no actual harm or negative clinical effect to the patient due to the reported problem, nor due to the prolonged anesthesia of 30-60 min.There are no further medical or surgical remedial actions necessary, done, or planned for this patient.Hospitalization was not prolonged either.

• Brand Name: NAVIGATION SOFTWARE CRANIAL EM (VERSION 1.1)
• 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 boyle ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 11020638
• MDR Text Key: 222006601
• Report Number: 8043933-2020-00067
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481132422
• UDI-Public: 04056481132422
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092467
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22240-06B
• Device Catalogue Number: 26555A
• Device Lot Number: SW V. 1.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2020
• 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