MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 3.1); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 22216-02C

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 01/12/2021

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since electrode leads were placed in a different location in the brain than anticipated, with the brainlab device involved, although according to the hospital: of the deviating leads, one was corrected in the very same surgery and the other two were determined to be in a close enough location to still provide the needed information (the position of the skull bolt for lead 9 apparently was also determined acceptable), the final outcome of the surgery is believed to be successful as intended (at the time the information was obtained), there was no (direct or increased) risk to harm a critical structure due to invasive steps done at this surgery, there was no harm/negative clinical effect for this patient due to this issue (at the time the information was obtained) (also not due to prolongation of anesthesia by 45 min), there are no further remedial actions necessary, done or planned for this patient due to this issue, nor was there a prolongation of hospitalization.According to the results of this brainlab technical investigation and the (limited) information provided by the hospital, it can be concluded that the root cause of the three inaccurately placed electrode leads, deviating anteriorly from their intended positions by approximately 9 to 10 mm at the entry point and 6.5 to 8.5 mm at the target point, was most likely a movement of the patient reference array during the procedure (after the 2nd airo ct scan and automatic image registration was performed) due to an insufficiently rigid fixation and/or inadvertently applied forces during (or after) the draping/undraping and sterile exchange process.Movement of the patient reference relative to the patient's head cannot be recognized by the navigation software and can result in a deviation between the registered intraoperative patient image, on which tracked instruments are displayed, and the actual patient anatomy.Apparently, the resulting deviation in navigation was not recognized by the surgeon with the appropriate and necessary accuracy verification checks - after draping and throughout the procedure - of the 2nd airo ct scan and registration.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 stereo-electroencephalography (seeg) surgery for placement of 10 electrode leads into the brain (indicated for the patient's epilepsy), has been performed with the aid of the brainlab cranial navigation version (b)(4) (on (b)(6) 2021).Trajectories were planned in a mri scan that was later fused to the intraoperatively acquired ct scans used for patient registration.During the procedure the surgeon: positioned the patient lateral in a non-brainlab head holder and attached the cranial 4-sphere drapelink reference array to the head holder, acquired an airo ct scan with automatic image registration (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, placed the first five electrode leads (lead 1 - 5) on the patient's left side with the aid of navigation: for each lead placement, the varioguide was aligned to the selected trajectory, a skin incision was made, a non-brainlab tube and drill were guided through the varioguide to create a burr hole, a non-navigated screwdriver was guided through the varioguide to secure the bolt (also non-navigated) to the skull at the burr hole, the navigated pointer was used to determine the depth of insertion that was marked on the electrode lead, the non-navigated electrode lead was guided down the skull bolt (without use of the varioguide) and secured into place.- repositioned the patient (lateral on the opposite side), acquired a 2nd airo ct scan with automatic image registration, verified the accuracy of the registration, and accepted the registration to proceed, placed three leads (lead 6 - 8) and the skull bolt for lead 9 (lead wasn't inserted yet) on the patient's right side with the aid of navigation, realized that those leads were not placed as intended (when checking the depart of the third lead (lead 8)), acquired a 3rd airo ct scan with automatic image registration, verified the accuracy of the registration, and accepted the registration to proceed, revised one of the three leads (lead 7), and determined the position of the two other leads (lead 6 and 8) and the skull bolt for lead 9 to be still acceptable, placed the last remaining lead (lead 10) with the aid of navigation, acquired a final 4th airo ct scan to verify lead placements and ended the procedure.According to the hospital: of the deviating leads, one was corrected in the very same surgery and the other two were determined to be in a close enough location to still provide the needed information (the position of the skull bolt for lead 9 apparently was also determined acceptable), the final outcome of the surgery is believed to be successful as intended (at the time the information was obtained, however, the patient had not had enough seizures yet to reconfirm), there was no (direct or increased) risk to harm a critical structure due to invasive steps done at this surgery, there was no harm/negative clinical effect for this patient due to this issue (at the time the information was obtained) (also not due to prolongation of anesthesia by 45 min), there are no further remedial actions necessary, done or planned for this patient due to this issue, nor was there a prolongation of hospitalization.

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 3.1)
• 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: 11320265
• MDR Text Key: 232164733
• Report Number: 8043933-2021-00009
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481132439
• UDI-Public: 04056481132439
• 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 Assistant
• Type of Report: Initial
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22216-02C
• Device Catalogue Number: 26615-02A
• Device Lot Number: SW V. 3.1.5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2020
• 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