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

Model Number	22240-06H
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A cranial surgery for a ventriculoperitoneal (vp) shunt placement into the lateral horn of the right ventricle, ca.9cm deep in the brain, to drain cerebrospinal fluid (csf) due to a hydrocephalus, has been performed with the aid of the brainlab navigation sw cranial em version 1.1.A pre-operative ct scan was acquired before the surgery the same day, to use with navigation.During the procedure the surgeons: - positioned the patient in a supine orientation with head turned left fixated in a non-brainlab horse shoe head holder, and attached the non-invasive em navigation reference to the patient's head.- performed the image registration of the ct scan to navigation, with landmark matching by acquiring registration points on the patient's skin surface with the em registration pointer, to match the display of the navigation to the current patient anatomy.- verified the accuracy of the patient registration to navigation, determined the result as less than optimal but sufficient for the intended placement, and accepted the registration to proceed.- exposed the skull at the intended placement location and determined the entry point for the burr hole with the navigated em disposable stylet, and marked this point.- created the burr hole with a size of ca.1.2cm in the patient's skull at the entry point and opened the dura, without using the navigation.- put the navigated em stylet inside the non-brainlab vp shunt catheter, and placed the shunt, following the navigation display to the target.- determined that the placement was not successful to reach the ventricle as desired, since there was no csf flow achieved from the shunt after removing the stylet.- performed several attempts to correct the shunt placement with the same navigated stylet method.- decided to use also available ultrasound imaging instead for the placement, extended the burr hole by ca.2mm and performed a few more shunt placement attempts with ultrasound only, until it was placed successfully to the desired target in the ventricle yielding csf flow.- completed the surgery successfully as intended and closed the patient.According to the fellow surgeon (treating clinician): - the deviation of the initial shunt placement was detected by the surgeon during the surgery with the missing csf flow, and the shunt placement was corrected at the very same surgery.- the final outcome of the surgery was successful as intended, with the shunt placed into the ventricle as desired and yielding csf flow.- there was no harm or negative clinical effect for this patient due to the deviating shunt placement attempts nor the slight burr hole extension, also not due to the surgery/anesthesia prolong of ca.20min.- there were further no remedial actions necessary, done or planned for this patient.Hospitalization was also not prolonged.
Additional Manufacturer Narrative
B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since shunt placement attempts were performed in a different location in the brain than anticipated and intended with the brainlab navigation involved, although according to the fellow surgeon (treating clinician): - the deviation of the initial shunt placement was detected by the surgeon during the surgery with the missing csf flow, and the shunt placement was corrected at the very same surgery.- the final outcome of the surgery was successful as intended, with the shunt placed into the ventricle as desired and yielding csf flow.- there was no harm or negative clinical effect for this patient due to the deviating shunt placement attempts nor the slight burr hole extension, also not due to the surgery/anesthesia prolong of ca.20min.- there were further no remedial actions necessary, done or planned for this patient.Hospitalization was also not prolonged.H6: 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 shunt placed in the brain with the aid of navigation deviating by ca.5mm from the intended path and target, is: - an insufficient distribution of surface landmark registration points acquired by the user for the patient anatomy registration to navigation, not following brainlab requirements.Navigation data provided for this surgery show that the points were collected - outside of brainlab recommendations - around areas subject to skin shift (eyes) and at the right ear, with skin shift visible at that location between pre and post ct data sets.Furthermore, the points were not distributed as required evenly around the head (most likely due to patient's head being rotated to the left restricting accessibility on both sides), and were not positioned at the also required region of interest.This caused the navigation software to not find an accurate as desired match for this specific procedure in between the preoperative image dataset and the actual patient anatomy in the region of interest.Despite an inaccuracy of the used registration to navigation was detected by the user with the required thorough verification of the registration accuracy (i.E.During the verification step), the resulting deviation in the region of interest between the actual anatomy location during the surgery and the registered pre-operative patient image scan displayed by the navigation for instrument position visualization was apparently not adequately recognized by the user - but accuracy deemed sufficient for this specific procedure - and also not 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.

• Brand Name: NAVIGATION SW CRANIAL EM 1.1
• Common Device Name: 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: markus hofmann ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 19490002
• Report Number: 8043933-2024-00032
• Device Sequence Number: 17898631
• Product Code: HAW
• UDI-Device Identifier: 04056481132422
• UDI-Public: 04056481132422
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K223288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 22240-06H
• Device Catalogue Number: 26555A
• Device Lot Number: SW V. 1.1.5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown