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

Model Number 22240-06C

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 03/01/2021

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since instrument paths were applied in a different location in the brain than anticipated, with the brainlab device involved, despite according to the hospital/surgeon: the position of the incorrectly placed shunt was corrected during this same procedure (the final/third placement, done without navigation, was successful).The outcome of the surgery was successful as intended.There was no direct (or increased) risk to harm a critical structure due to this issue.There was no actual harm/negative clinical effect to the patient due to this issue.There are no further medical/surgical remedial actions necessary, done or planned for this patient due to this issue; prolongation of hospitalization was not required either.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 two inaccurate ventriculoperitoneal (vp) shunt placement attempts, performed with the aid of navigation, that did not produce the expected cerebrospinal fluid (csf) was a suboptimal patient registration (accepted by the user) due to the use of a suboptimal patient scan for surface matching registration and/or a suboptimal distribution of registration points acquired by the user that did not completely follow brainlab recommendations.The preoperative patient scan used for patient registration had a distortion over the bridge of the nose that did not match to the patient's actual anatomy at the procedure.Registration points were acquired over this area and other areas of potential skin shift (e.G.Along left eyebrow), which could have negatively affected the calculated registration match.Additionally, the overall point acquisition could have been more widely and evenly distributed over the right and left sides of the patient's forehead.The combination of a suboptimal patient scan and point acquisition for surface matching registration likely resulted in a final registration that was less accurate than desired by the user (especially at the region of interest) for the procedure to be performed.Apparently, the resulting deviation of the registered preoperative image from the actual patient anatomy in the navigation display was not recognized by the user with the appropriate and necessary accuracy verification - particularly at the region of interest - during the verification step (directly after registration and before accepting) nor throughout the procedure, prior to performing the navigated vp shunt passes.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 re-iterate the relevant topics regarding the use of the device to this customer.

Event Description

A cranial surgery for a ventriculoperitoneal (vp) shunt placement to drain cerebrospinal fluid (csf) from the superior portion of the right ventricle (approx.46.4 mm in depth), has been performed with the aid of the brainlab navigation software cranial em 1.1 (on (b)(6) 2021).A pre-operative ct scan was acquired the same day, to use with navigation.A trajectory was created preoperatively targeting the right ventricle (entry point was intended to be navigated/adapted intraoperatively).During the procedure the surgeon: positioned the patient in supine position with head turned to the left on a non-brainlab horseshoe head holder.Secured the patient reference (non-invasive) to the patient's forehead with tape.Performed the initial patient registration on the preoperative ct scan 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 determined it not sufficiently accurate performed a new patient registration, but with the patient head positioned supine, verified the accuracy of the registration and determined it (not ideal but) sufficiently accurate.Turned the patient head to the left and verified accuracy of the registration again.Updated the entry point of the planned trajectory (twice until a satisfactory result was achieved) and marked the entry point with a pen on the skin.Draped the patient, made the skin incision, and created the burr hole (without aid of navigation).Placed the navigated disposable em stylet into a non-brainlab non-navigated catheter and aligned it to the burr hole, and updated the entry point (in navigation) once more passed the catheter/disposable stylet down, following the trajectory, but did not get any csf returned.Removed and flushed the catheter, and updated the entry point (in navigation) again.Passed the catheter/disposable stylet down again, following the trajectory, and still did not get any csf returned.Abandoned use of navigation and passed the catheter a third time, and was able to successfully get csf returned.According to the hospital: the position of the incorrectly placed shunt was corrected during this same procedure (the final/third placement, done without navigation, was successful).The outcome of the surgery was successful as intended.There was no direct (or increased) risk to harm a critical structure due to this issue.There was no actual harm/negative clinical effect to the patient due to this issue.There are no further medical/surgical remedial actions necessary, done or planned.For this patient due to this issue; prolongation of hospitalization was not required either.

• Brand Name: CRANIAL EM NAVIGATION SOFTWARE (VERSION 1.1)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer Contact: andrea miller ; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• MDR Report Key: 11567047
• MDR Text Key: 260080847
• Report Number: 8043933-2021-00019
• 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: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22240-06C
• Device Catalogue Number: 22240-06C
• Device Lot Number: SW V. 1.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2018
• 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