MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 2.1.2); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 22214-02D

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

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

Event Date 06/30/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since a visualase wire was not placed as intended, with the brainlab device involved, although: - there is no indication of a systematic error or malfunction of the brainlab device.- corresponding measures to minimize this anticipated risk as low as reasonably practicable are already in place.- according to the hospital, there was no increased risk to harm critical structures for this specific patient, the procedure was completed successfully, and there was no negative clinical effect to the patient due to this issue (also not due to surgery delay/prolonged anesthesia).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 visualase wire not placed as intended is one or a combination of the following factors: - during initial patient registration the software did not find a match to actual patient anatomy that was as accurate as desired for this specific patient/surgery, due to the fact that the registration point acquisition was not performed in the recommended area and the camera was moved during the registration procedure.- the navigation reference array and/or the patient's head in the head holder might have moved during the surgery, due to a not sufficient rigid fixation, leading to a deviation of position information in the navigation software.- slight slipping of the drill on the skin/skull bone occurred or too much pressure was put on the varioguide while drilling, leading to a deviation of position information in the navigation software.Apparently the deviation was not detected during the according accuracy verification to be performed by the user.Note: the varioguide is intended for use on targets with a diameter larger than 8 mm.It seems the user was not aware of the recommended target size for use of the varioguide.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 inform this hospital about the investigation results.Corresponding to the root cause, brainlab intends to re-iterate the relevant topics regarding the use of the device to this customer.

Event Description

A cranial surgery for placement of a visualase wire (for laser ablation in the right ventricle) was performed with the aid of the brainlab cranial 2.1.2 navigation software.During the procedure the surgeon: - registered the actual patient anatomy to the navigation (to the mri scan imported into and used by the navigation system).- verified and accepted the patient registration in the navigation.- planned a trajectory (target area approx.5x5 mm in size).- marked the entry point on the patient skin using aid of navigation (brainlab pointer).- draped the patient and exchanged the unsterile reference array for a sterile one.- setup the (3rd party) drill guide according to the pre-planned trajectory with the aid of navigation (brainlab varioguide).- drilled the burr hole and screwed a bone anchor (to guide the visualase wire) into the bone.- placed the rigid visualase wire through the bone anchor.- obtained a mri scan and detected a deviation of approx.5 mm between planned and actual trajectory (investigation confirmed 3.6 mm deviation in target point).- determined that the placement is not acceptable for performing laser ablation.- decided to repeat the procedure without aid of navigation.According to the hospital, there was no increased risk to harm critical structures for this specific patient, the procedure was completed successfully (without aid of brainlab navigation), and there was no negative clinical effect to the patient due to this issue (also not due to surgery delay/prolonged anesthesia).

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 2.1.2)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622
• Manufacturer (Section G): BRAINLAB AG; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622
• Manufacturer Contact: andrea miller ; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622 ; 89 9915680
• MDR Report Key: 5828808
• MDR Text Key: 50618849
• Report Number: 8043933-2016-00027
• Device Sequence Number: 1
• Product Code: HAW
• 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: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 22214-02D
• Device Catalogue Number: 71208
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2015
• 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