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); Misassembly by Users (3133)

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

Event Date 11/20/2017

Event Type  malfunction  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since catheters were placed in a different location in the brain than anticipated with the brainlab device involved, and the desired treatment (drug delivery for glioma) could not be applied as intended, despite according to the surgeon: - the burr holes were not changed or increased.- misplacement of the catheters was detected in the post-op mri scan, when reviewing if the infusion started properly.The infusion was stopped immediately when it appeared in a different area than intended, the catheters were removed, the patient closed and woken up.- there were no negative effects to the patient, neither due to the catheter placements nor due to surgery/anesthesia time.- there was no harm to a critical brain structure.- there is no revision surgery necessary nor planned.- there are no remedial actions necessary, done or planned for this patient.Hospitalization did not need to be prolonged 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 catheters placed in a different location in the brain than anticipated with navigation involved, is that a shift of the navigation reference array most probably occurred after draping and likely during the exchange from unsterile to sterile array, due to not proper attachment.This led to a navigation display of instrument positions different than originally registered to the mri scan.Further factors that to a lesser extend might have additionally contributed: - the image fusion in between the scans had a slight deviation due to the difference in patient head positions.This slight deviation was apparently not detected by the user with the necessary verification of the fusion result.- the unsterile marker spheres used on the unsterile instruments during registration and (direct) verification of registration were not new/unused as required.- a shift of the patient's brain might have occurred in between the mri and the anatomical situation during the surgery, e.G.Due to the bone flap and/ or loss of cerebrospinal fluid.Apparently the resulting deviation between displayed navigation information and the actual patient anatomy was not detected with the necessary continuous accuracy verification by the user.There is no indication of a systematic error or malfunction of the brainlab device (navigation).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 catheter placements for drug infusion to a glioma with a size of ca.6ccm, located ca.3cm deep in the brain, has been performed with the aid of the brainlab navigation version 3.1.Pre-operative mri scans were acquired 12 days before the surgery, as well as a further pre-op mri scan at the day of surgery, to use with navigation.Trajectories were planned for the procedure, and the scans were fused.During the procedure the surgeon: - positioned the patient in a supine orientation, with head turned 30-40 degrees to the left, in a head holder.- performed an intraoperative mri scan and the initial automatic patient registration to match the display of the navigation on this image set to the current patient anatomy.- verified the accuracy of the automatic registration and determined the result as good.- removed the unsterile navigation reference array and draped the patient.- attached a sterile reference array, and re-verified accuracy, and created the burr holes.- used the navigated instrument guide to create the burr hole (craniotomy, ca.4mm diameter) and to place the catheter aligning to the planned trajectory.- performed the same for the 3 further burr holes and catheters, until all 4 catheters were placed.A post-op mri scan, performed to review if the drug infusion starts properly, indicated that the catheters were placed ca.4cm away from the intended targets.Correspondingly, the infusion was stopped immediately.The catheters were removed, the patient was closed and woken up without any further issue.According to the surgeon: - the burr holes were not changed or increased.- misplacement of the catheters was detected in the post-op mri scan, when reviewing if the infusion started properly.The infusion was stopped immediately when it appeared in a different area than intended, the catheters were removed, the patient closed and woken up.- there were no negative effects to the patient, neither due to the catheter placements nor due to surgery/anesthesia time.- there was no harm to a critical brain structure.- there is no revision surgery necessary nor planned.- there are no remedial actions necessary, done or planned for this patient.Hospitalization did not need to be prolonged 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; münchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer Contact: markus hofmann ; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• MDR Report Key: 7111948
• MDR Text Key: 95771094
• Report Number: 8043933-2017-00032
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481000479
• UDI-Public: 04056481000479
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 22216A
• Device Catalogue Number: 22216A
• Device Lot Number: SW V. 3.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2017
• 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