MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 2.1); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 22214C

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2018

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since a biopsy was performed in another location in the brain than intended, with the brainlab device involved, and the desired diagnostic sample was not retrieved, although: there is no indication of a systematic error or malfunction of the brainlab navigation device, and according brainlab measures to minimize this anticipated risk as low as reasonably practicable are already in place according to the hospital, the reason for the non-diagnostic result is unclear (may also be because the lesion is of low cellularity), there was no risk to harm a critical structure due to the actual biopsy resection, there are no negative clinical effects for this specific patient due to this issue, there were no remedial actions necessary/planned/done for this patient, the surgery was not delayed, hospitalization was not prolonged, a revision surgery is not planned to be done at this stage.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 observed deviation between planned and actual trajectory is a potential movement of the navigation reference array during draping and exchange from unsterile to sterile array, due to a not sufficient rigid fixation (caused by worn teeth on the reference array).Further contributing factors: the patient's head in the head holder might have moved during the surgery due to a not sufficient rigid fixation (user did not check if it was possible to move the patient's head in the head holder).No new ndi drms used for unsterile equipment/array, which might lead to deviation in positioning information displayed by navigation apparently the deviation has not been recognized by the user with the necessary continued verification of accuracy throughout the procedure.There is no indication of a systematic error or malfunction of the brainlab navigation device.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, and advices to discontinue use of arrays with worn teeth.

Event Description

A right side brainstem biopsy was planned to be performed with the aid of the brainlab cranial navigation system version 2.1.2 (on (b)(6) 2018).The tumor dimension was about 19.5 mm in diameter, and located about 65 mm from the surface.Surgery goal was to obtain a diagnostic sample (not to remove/treat lesion), with biopsy window above the target.7 donut markers were placed on the patient head, and pre-operative mri scans (t1 and t2) were acquired on the surgery day, for use with navigation.During the surgery, the surgeon/health professional: positioned the patient in supine orientation (with head tilted to the left) and attached the 3 sphere standard cranial reference array for navigation performed the initial patient registration on the pre-operative mri t1 scan (to match the display of the navigation to the current patient anatomy) verified accuracy of the registration, and determined it good for this procedure draped the patient and exchanged the unsterile reference array for a sterile one (verified accuracy only in region of interest, no further accuracy verification was possible since draped for burr hole).Assembled the varioguide.Planned the burr hole entry using aid of navigation.Moved the varioguide into rough position.Re-assessed the burr hole entry using aid of navigation.Created a burr hole of 7 mm.Aligned the varioguide (completed this step twice, with software indicating 0.5 mm target.Deviation for the second/accepted alignment).Prepared brainlab biopsy needle.Passed needle through varioguide, took a 4-quadrant-biopsy (1 pass with 4 samples taken).Observed effects on the patient when last sample was taken (patient's heart rate jumped high temporarily, and some blood was shown in the last sample).Decided to send all specimens to pathology.Obtained information that samples were non-diagnostic.Decided to leave biopsy as is (no additional paths/samples done), and ended the case.Obtained a post-op mri on (b)(6) 2018, and realized a deviation of about 1 cm between planned and actual trajectory (in target as well as entry point) according to the hospital, the reason for the non-diagnostic result is unclear (may also be because the lesion is of low cellularity), there was no risk to harm a critical structure due to the actual biopsy resection, there are no negative clinical effects for this specific patient due to this issue, there were no remedial actions necessary/planned/done for this patient, the surgery was not delayed, hospitalization was not prolonged, a revision surgery is not planned to be done at this stage.

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 2.1)
• 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: 7999091
• MDR Text Key: 124807392
• Report Number: 8043933-2018-00037
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481000493
• UDI-Public: 04056481000493
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K092467
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22214C
• Device Catalogue Number: 71208
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2015
• 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