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

Model Number 22216-01A

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2019

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since instrument paths and biopsy resections were applied in a different location in the brain than anticipated, with the brainlab device involved, despite according to the surgeon: there was no (direct or increased) risk to harm a critical brain structure (e.G.Blood vessels or important brain tissue) due to an actual biopsy resection or path actually applied (trajectory was short and avascular).There were no negative effects to the patient.There was no delay of the surgery nor of anesthesia due to this issue.There are no remedial actions necessary, done or planned for this patient.There was no prolong of hospitalization 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 navigation display compared to the actual patient anatomy by approximately 1.5 cm is likely a combination of the following: the patient's head may have moved inside the head holder during the surgery, and in relation to the navigation reference array.The navigation reference array may also have moved due to forces applied during draping and undraping of the reference array during the surgery, because of visibility issues.No new brainlab compatible drms (disposable reflective marker spheres) were used for the unsterile equipment (softouch) nor for the reference array and the reference array was additionally draped (instead of the brainlab recommended exchange from unsterile to sterile reference), both of which may lead to deviation in positioning information displayed by navigation.Apparently the deviation has not been recognized (prior to performing the biopsy) 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.

Event Description

A cranial surgery for a biopsy (diagnostic sample) of a left parietal brain tumor located 4cm cranio-caudal, 4.4cm antero-posterior, and 2.6cm medio-lateral, with the most superficial part ca.2cm deep in the brain with a size of ca.3x3x3cm, has been performed with the aid of brainlab navigation version 3.1.A pre-operative mri scan was acquired 1 day prior to the surgery, to use with navigation.A trajectory was planned on the mri scan using brainlab elements.During the procedure the surgeon: positioned the patient in a supine orientation with the head tilted to the right in a non-brainlab head holder and attached the brainlab 4-sphere standard cranial reference array for navigation.Performed the initial patient registration on the pre-op mri with fiducial markers attached on the skin of the patient, to match the display of the navigation to the current patient anatomy.Verified the accuracy of the registration on the patient's skin with anatomical landmarks, and judged the navigation accuracy achieved at 5 of the 6 fiducial markers to be very good, with slightly less accuracy at 1 fiducial marker, but deemed acceptable overall.Draped the unsterile navigation reference array with a transparent drape and draped the patient.Used the brainlab pointer to determine the location of the burr hole for the desired approach, and created a burr hole (craniotomy) of > 1 cm.Aligned the varioguide to the planned trajectory.Encountered visibility problems between the infrared camera and the cranial reference array at some point during the surgery, and removed the transparent drape from the cranial reference array.Used a navigated brainlab compatible biopsy needle to collect tissue samples following the planned trajectory (1 pass, 12 samples taken - 4 post-target, 4 on target, and 4 pre-target).A small amount (less than expected) of the tissue sample was pathological, but not all molecular markers could be determined.Closed the patient and completed the surgery.A post-operative ct scan was performed two days after the surgery on (b)(6) 2019, which indicated the biopsy was performed on the edge of the tumor, instead of the planned center of the tumor, with ca.1.5cm deviation from the planned target.The actual entry point deviated from the intended entry 8mm caudally and 5mm medially, with a similar deviation between the actual target and intended target.According to the surgeon: there was no (direct or increased) risk to harm a critical brain structure (e.G.Blood vessels or important brain tissue) due to an actual biopsy resection or path actually applied (trajectory was short and avascular) there were no negative effects to the patient.There was no delay of the surgery nor of anesthesia due to this issue.There are no remedial actions necessary, done or planned for this patient.There was no prolong of hospitalization either.

• 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; 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: 8461634
• MDR Text Key: 140336815
• Report Number: 8043933-2019-00008
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481000479
• UDI-Public: 04056481000479
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22216-01A
• Device Catalogue Number: 22216B
• Device Lot Number: SW V. 3.1.3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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