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U.S. Department of Health and Human Services

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

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BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 3.1) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC Back to Search Results
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.
 
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Brand NameCRANIAL NAVIGATION SOFTWARE (VERSION 3.1)
Type of DeviceIMAGE 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 Key7111948
MDR Text Key95771094
Report Number8043933-2017-00032
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K092467
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received12/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number22216A
Device Catalogue Number22216A
Device Lot NumberSW V. 3.1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/13/2017 Patient Sequence Number: 1
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