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

Model Number 22216A

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2019

Event Type  Injury  

Manufacturer Narrative

Outcomes to adverse event, type of reportable event: a risk to the patient's health could not be excluded for these specific circumstances, since biopsy path and resections were applied in a different location in the brain than intended, with the brainlab device involved, despite according to the surgeon: there was no (direct or increased) risk to harm a critical structure due to this issue; there was no negative clinical effect for this patient due to this issue; diagnostic samples were obtained; the patient was put on antibiotics, and is responding well, in that lesion size has decreased; there was no prolongation of surgery/anesthesia time nor a prolongation of hospitalization due to this issue; there are no remedial actions necessary, done or planned for this patient due to this issue.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 actual biopsy path compared to the planned trajectory is a combination of the following: a less than ideal point acquisition by the user during patient registration, not completely following the brainlab recommendations as required (e.G.Minimal registration points in the front of the face), may have caused the brainlab cranial navigation software to not find an as accurate match as desired in the region of interest for this specific biopsy procedure, between the preoperative image dataset and the actual patient anatomy.A potential bending of the bendable biopsy needle may have increased the initially smaller deviation at the entry point along the trajectory path.The navigation reference array may have moved during the procedure due to a not sufficient rigid fixation, and/ or the patient's head in the (non-brainlab) head holder might have moved during the surgery.Regarding the alleged deviation in depth between planned and actual trajectory, the root cause could not be determined.Note regarding the magnitude of the alleged deviation: the data confirm a slight angular deviation of the biopsy path (about 4 mm at alleged target point), and suggest that likely not the intended lesion center was aspirated.The pathology result suggests that the samples were not taken from the center of the lesion, but nearby.The location where the samples were taken (i.E.The actual depth of the trajectory) is not visible in the data.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.Remedial action initiated: 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) has been performed with the aid of brainlab navigation version 3.1.1 (on (b)(6) 2019)).The lesion was located about 30-35 mm deep from the planned frontal approach, and had a length of about 11.5 mm.A pre-operative mri scan was acquired 2 days prior to the surgery, to use with navigation.During the procedure the surgeon: positioned the patient in a supine orientation and attached the brainlab 4-sphere standard reference array for navigation; performed the initial patient registration on the pre-operative mri scan (surface registration using softouch) to match the display of the navigation to the current patient anatomy; verified the accuracy of the registration (by checking facial features / top of head) and judged the registration accuracy to be good; created a trajectory using the softouch (with enabled offset); marked the entry point on the patient skin; draped the patient and exchanged the unsterile reference array for a sterile one; rechecked the planned incision and trajectory with the sterile pointer, then created a burr hole of 20-30 mm (without aid of navigation); assembled and setup the varioguide and aligned it to the planned trajectory; performed the biopsy (2 passes, collecting 4 samples) using the brainlab-distributed (pajunk) biopsy needle, and performed an aspiration; obtained information from pathology that samples were inconclusive but abnormal; completed the surgery.In a post-operative ct scan obtained on (b)(6) 2019, the surgeon realized that the actual trajectory deviates from the planned trajectory, and he suspected that neither the samples were taken from nor the aspiration was performed within the lesion (he suspected the actual trajectory had a slight angular deviation and a reduced depth of 9 mm, leading to an alleged deviation in target point of 11.5 mm).According to the hospital/surgeon: there was no (direct or increased) risk to harm a critical structure due to this issue; there was no negative clinical effect for this patient due to this issue; diagnostic samples were obtained; the patient was put on antibiotics, and is responding well, in that lesion size has decreased; there was no prolongation of surgery/anesthesia time nor a prolongation of hospitalization due to this issue; there are no remedial actions necessary, done or planned for this patient due to this issue.

• 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: 8525981
• MDR Text Key: 142385260
• Report Number: 8043933-2019-00014
• 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
• Type of Report: Initial
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22216A
• Device Catalogue Number: 71205
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2017
• 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