MAUDE Adverse Event Report: BRAINLAB AG NAVIGATION SW CRANIAL UNLIMITED (VERS. 1.0.1); IMAGE GUIDED SURGERY SYSTEM/STEREOT.

Model Number 22208A

Device Problems Difficult To Position (1467); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

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

Event Date 04/20/2015

Event Type  No Answer Provided  

Event Description

A cranial surgery for the placement of catheters for laser ablation has been performed with the aid of the brainlab device.During the procedure the surgeon performed the initial pt registration to match the virtual display of preoperative scans to the current pt anatomy and verified the accuracy of registration with a satisfying result.Placed two catheters with the aid of brainlab navigation according to preplanned trajectories.Performed an intraoperative mri scan to confirm the correct placement of catheters and detected that their position was not as intended.Removed the catheters, performed a new intraoperative scan and a new pt registration and placed two new catheters with the aid of navigation.Again performed an intraoperative scan for verification and detected that the position of the catheters was again not as intended.One of the catheters could be used to ablate the tumor.The second catheter was not in an acceptable position to do so, so the surgeon decided to remove the catheters and discontinued the surgery.According to the hosp there was no negative clinical effect to the pt due to the misplaced laser fiber.

Manufacturer Narrative

Although according to the hosp there are no negative clinical effects for this pt due to this issue, a risk to the pt's health could not be excluded for these specific circumstances, since apparently the catheters were placed in another region of the brain than intended with the brainlab device involved.A comprehensive investigation by brainlab regarding this specific event is currently ongoing and final conclusions are pending.Brainlab plans to issue a f/u report to the fda upon completion of investigation.

Manufacturer Narrative

Despite a comprehensive investigation has been performed, a definite root cause could not be determined for this specific issue.Most plausible root cause is the use of marker spheres that were not determined as compatible by brainlab, instead of compatible brainlab/ndi disposable reflective marker spheres.The spheres used in this specific case could not be threaded down completely to the array.This can lead to an inaccurate tracking of pre-calibrated tools since the center of the sphere is not in the correct position.Brainlab has not validated any marker spheres other than drms manufactured by brainlab or ndi in conjunction with brainlab igs systems, and therefore brainlab is not in a position to determine the accuracy, compatibility or safety of any other marker spheres.There is no indication of a systematic error or malfunction of the brainlab navigation device.Corresponding brainlab measures to reduce these already anticipated risks to be as low as reasonably practicable are in place.Brainlab intends to offer an additional training to this hospital.

• Brand Name: NAVIGATION SW CRANIAL UNLIMITED (VERS. 1.0.1)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/STEREOT.
• Manufacturer (Section D): BRAINLAB AG; kapellenstrasse 12; feldkirchen 85622 ; GM 85622
• Manufacturer Contact: julia mehltretter ; kapellenstrasse 12; feldkirchen 85622 ; GM 85622 ; 99915680
• MDR Report Key: 4795948
• MDR Text Key: 16075758
• Report Number: 8043933-2015-00008
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22208A
• Device Catalogue Number: 22208-11
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2011
• 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