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 04/27/2019

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 paths were applied in a different location in the brain than intended, with the brainlab device involved, despite according to the surgeon: the final outcome of the surgery was successful (when the expected tissue samples could not be obtained at the two initial passes, the surgeon extended the burr hole to a small craniotomy and extracted the cyst with aid of navigation at the same surgery).There was no harm to a critical structure due to the unsuccessful passes.There were no negative clinical effects to the patient reported due to this issue.There were no further remedial actions reported that would have been necessary, done, or planned for this patient, nor was a prolongation of hospitalization reported.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 applied biopsy paths compared to the intended path by less than 1 cm, is a combination of the following: a less than ideal point acquisition by the user during patient registration (e.G.Minimal registration points in the region of interest), 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 less than ideal assembly of the frameless biopsy system may have led to potential bending of the bendable biopsy needle thereby leading to an inaccurate tracking by the brainlab cranial navigation software, and deviated path placement.Further contributing factor: no new ndi drms used for unsterile equipment, which might lead to deviation in positioning information displayed by navigation.Additional factor related to patient anatomy/ cyst structure: the cyst may have additionally deformed and may not have allowed an easy penetration of the biopsy needle.It is also possible (depending on where the planned trajectory was supposed to penetrate, mainly at the edge of the cyst) that the needle 'slipped off', leading to an inconclusive biopsy/ deviated path.Apparently the deviation has not been recognized by the user (prior to performing the biopsies) 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 extraction of a cranial cyst has been performed with the aid of brainlab navigation version 3.1.0 ((b)(6) 2019).The cyst was located in the left occipital region, about 3 cm from the surface coronal and 7.5 cm sagittal, its diameter was about 2.5 cm, and it had a volume of 16 cc.A pre-operative mri scan was acquired 2 days prior to the surgery, to use with navigation, and the cyst had been outlined by the surgeon.During the procedure the surgeon: positioned the patient in a lateral orientation and attached the 4-sphere standard reference array for navigation.Performed the initial patient registration on the pre-operative mri scan (surface matching using softouch and z-touch) to match the display of the navigation to the current patient anatomy.Verified the accuracy of the registration and judged it as very good.Planned position of the burr hole with aid of navigation (pointer).Assembled and setup the brainlab frameless biopsy system and aligned it roughly to the intended location.Planned a trajectory (with offset enabled; offset length was not transferred to the biopsy needle using a stopper, since the cyst was quite large).Had issues inserting the brainlab-distributed (pajunk) biopsy needle into the biopsy tube, and therefore loosened the tube inserts.Performed the biopsy, and detected that the tissue samples obtained did not contain the expected cystic lesion.Checked instrumentation, verified accuracy of registration and judged it acceptable.Performed another pass, but again could not obtain the expected samples.Decided to extend the burr hole to a small craniotomy.Verified registration accuracy again and judged it acceptable.Found the cyst with aid of navigation and extracted the cyst (deviation was approximated to be less than 1 cm).According to the hospital/surgeon: the final outcome of the surgery was successful (when the expected tissue samples could not be obtained at the two initial passes, the surgeon extended the burr hole to a small craniotomy and extracted the cyst with aid of navigation at the same surgery).There was no harm to a critical structure due to the unsuccessful passes.There were no negative clinical effects to the patient reported due to this issue.There were no further remedial actions reported that would have been necessary, done, or planned for this patient, nor was a prolongation of hospitalization reported.

• 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: 8611249
• MDR Text Key: 145112756
• Report Number: 8043933-2019-00022
• 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: 04/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22216A
• Device Catalogue Number: 71202A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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