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U.S. Department of Health and Human Services

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

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BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 2.1.2) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 22214C
Device Problems Use of Device Problem (1670); Human Factors Issue (2948); Device Handling Problem (3265)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/01/2016
Event Type  No Answer Provided  
Manufacturer Narrative
A risk to the patient's health could not be excluded for these specific circumstances, since catheters for drainage of an intra-cerebral bleeding were placed in a different location in the brain than intended, with the brainlab device involved, and in this specific case a second surgery was done for the treatment to be sufficiently effective, despite according to the surgeon: - drainage of blood was possible with first catheter placement, with reduction of hemorrhage from ca. 74cm³ to 50cm³. - with second catheter placement the next day, further drainage was possible with a further hemorrhage reduction to ca. 30cm³. - there was no further adaptation of catheter placement decided: the hemorrhage could be drained sufficiently with placement of the second surgery. - there were no negative clinical effects to the patient reported due to the catheter placements. - there are no further remedial actions necessary, done or planned for this patient (other than the second surgery performed). According to the results of brainlab investigation and the information provided by the hospital, it can be concluded that the root cause for the less than ideal drainage catheter placements is a combination of the following factors: - the pre-operative ct scan used with navigation at both surgeries was not performed according to the brainlab scan protocol, and contained significant skin shift due to a headband applied to the patient only during the scan. - the registration points acquired by the user during surface matching to register the anatomy to the pre-op ct were not adequately and sufficiently distributed at both surgeries, as required by the navigation software (and did also not contain registration points in the region of interest, i. E. The back of the head). Apparently the resulting deviation between virtually displayed navigation information and the actual patient anatomy was not detected during the required accuracy verification to be performed 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. 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 catheter placement to drain an intra-cerebral hemorrhage (temporal left side), with a size of ca. 74cm³, was performed with the aid of the brainlab cranial navigation system. A pre-operative ct scan was acquired the same day before the surgery to use with navigation. This pre-op ct scan contained significant skin shift due to a headband applied to the patient only during the scan. A trajectory for catheter placement was planned using this pre-op ct scan. During the procedure the surgeon: - positioned the patient in a lateral sitting position in a non-brainlab head holder. - performed the initial patient registration on the pre-op ct with registration points taken on the face of the patient to match the virtual display of the navigation to the current patient anatomy. - verified the accuracy of the registration on the patient's skin (not including the back of the head where the planned entry was located) to be acceptable for use. - draped the patient, performed the craniotomy, aligned a navigated biopsy needle used as guidance for the catheter and placed the catheter for drainage. A post-op ct scan was performed the next day, and showed that the catheter was not ideally placed. The target point was only roughly hit, still drainage of blood was possible with this placement, with reduction of hemorrhage from ca. 74cm³ to 50cm³. It was decided to perform a second surgery for another (adjusted) catheter placement on this next day. A new trajectory was planned using the same original pre-op ct scan, for use with the same navigation sw. The second surgery for catheter placement was performed, using the same technique as for the first placement the day before. Another post-op ct was performed, showing that the second surgery also did not result in an ideal placement of the catheter. Still further drainage was possible with this second catheter placement, with a further hemorrhage reduction to ca. 30cm³. There was no further adaptation of catheter placement decided: the hemorrhage could be drained sufficiently with placement of the second surgery. According to the surgeon: - drainage of blood was possible with first catheter placement, with reduction of hemorrhage from ca. 74cm³ to 50cm³. - with second catheter placement the next day, further drainage was possible with a further hemorrhage reduction to ca. 30cm³. - there was no further adaptation of catheter placement decided: the hemorrhage could be drained sufficiently with placement of the second surgery. - there were no negative clinical effects to the patient reported due to the catheter placements. - there are no further remedial actions necessary, done or planned for this patient (other than the second surgery performed).
 
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Brand NameCRANIAL NAVIGATION SOFTWARE (VERSION 2.1.2)
Type of DeviceIMAGE 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
markus hofmann
kapellenstrasse 12
feldkirchen, 85622
GM   85622
89 9915680
MDR Report Key6072070
MDR Text Key58926651
Report Number8043933-2016-00039
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeGM
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 10/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number22214C
Device Catalogue Number71208
Device Lot NumberSW V.2.1.2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/07/2015
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: 11/02/2016 Patient Sequence Number: 1
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