MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 2.1); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 22214-02D

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Use of Device Problem (1670); Malposition of Device (2616); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2019

Event Type  Injury  

Manufacturer Narrative

Outcomes to adverse event, type of reportable event: a risk to the patient's health could not be excluded for these specific circumstances, since instrument paths and tissue resections were applied in a different location in the brain than anticipated, with the brainlab device involved, despite according to the surgeon: there was no (direct or increased) risk to harm a critical brain structure (e.G.Blood vessels or important brain tissue) due to an actual biopsy resection or path actually applied.There were no negative clinical effects for this patient, and there was no prolongation of surgery / anesthesia.A revision surgery is planned to retrieve a diagnostic sample but not yet scheduled.There are no (other) remedial actions necessary, done or planned for this patient.There is a planned prolong of hospitalization only for the planned revision surgery.Currently there is no indication of a systematic error or malfunction of the brainlab device, nor of insufficient measures to minimize this anticipated risk as low as reasonably practicable remedial action initiated: a comprehensive investigation by brainlab regarding this specific event is currently ongoing and final conclusions are pending.Brainlab plans to issue a follow-up report to the fda upon completion of investigation.

Event Description

A cranial surgery for biopsy (diagnostic sample) of a brain tumor was performed with the aid of the brainlab navigation software cranial 2.1.An mri scan was acquired pre-operatively on (b)(6) 2019 to use with navigation.Trajectory and registration points were planned on the scans pre-operatively in the brainlab navigation software the day of the surgery.During the procedure the surgeon: positioned the patient in a supine orientation in a non-brainlab head holder and attached the unsterile reference array.Performed the initial patient registration on the pre-op mri using the pointer acquiring 10 registration points on the patient's skin to match the display of the navigation to the current patient anatomy.Verified the accuracy of the registration and accepted the registration to proceed.Updated the planned entry point of the pre-planned trajectory using the pointer and the aid of navigation.Removed the unsterile navigation reference array and draped the patient.Attached a sterile reference array, re-verified navigation accuracy, and determined the burr hole placement with the aid of navigation.Attached and aligned the varioguide to the planned trajectory.Used the brainlab distributed (pajunk) biopsy needle inserted to the varioguide to collect tissue samples, which were sent to pathology for diagnosis.Completed the surgery.The tissue collected was determined to be non-diagnostic by pathology.A post-operative ct showed there was a 1cm deviation medially and laterally from the intended and planned target.The entry point was in the intended location.A revision surgery is planned but not yet scheduled.According to the surgeon: there was no (direct or increased) risk to harm a critical brain structure (e.G.Blood vessels or important brain tissue) due to an actual biopsy resection or path actually applied.There were no negative clinical effects for this patient, and there was no prolongation of surgery / anesthesia.A revision surgery is planned to retrieve a diagnostic sample but not yet scheduled.There are no (other) remedial actions necessary, done or planned for this patient.There is a planned prolong of hospitalization only for the planned revision surgery.

Manufacturer Narrative

B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since biopsies were applied in a different location in the brain than anticipated with the brainlab device involved, and the desired diagnostic specimen was not retrieved, despite according to the surgeon: - there was no (direct or increased) risk to harm a critical brain structure (e.G.Blood vessels or important brain tissue) due to an actual biopsy resection or path actually applied.- there were no negative clinical effects for this patient, and there was no prolongation of surgery / anesthesia.- a revision surgery is planned to retrieve a diagnostic sample but has not yet occurred.- there are no (other) remedial actions necessary, done or planned for this patient.- there is a planned prolong of hospitalization only for the planned revision surgery.H6: 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 deviation of the actual trajectory applied, compared to the planned trajectory displayed by the navigation, by ca.1cm can be attributed to the combination of the following factors: - a shift/displacement of the donut registration markers in between the time of the scan acquisition and the time of patient registration by the user (due to movement of the markers overnight or from skin shift caused by the pins of the headframe during surgery) may have caused the brainlab cranial navigation software to not find a match of the preoperative image dataset to the current actual patient anatomy at the time of surgery, that was as accurate as desired in the region of interest for this specific biopsy procedure.- a shift of the patient's brain may have occurred in between the preoperative image data used with navigation and the changed anatomical situation during the surgery, e.G.Due to the burr hole and/ or loss of cerebrospinal fluid.This shift of the patient's brain cannot be recognized or compensated by the navigation, which uses the preoperative image data for display of instrument positions relative to the patient's anatomy.- the customer used 3rd party marker spheres which have not been validated by brainlab.Brainlab has not validated any marker spheres other than the ones manufactured by brainlab or ndi in conjunction with brainlab igs (navigation) systems, and therefore brainlab is not in a position to determine the accuracy, compatibility or safety of the other, 3rd party marker spheres used by this customer for the surgery in combination with the brainlab navigation.- additionally two of the hospital's instruments have been found damaged due to long term use or rough handling during use or re-processing.Despite brainlab is not in a position to fully confirm, of the instruments available to this user site, if and which of these two damaged instruments were actually used at this specific surgery: -- one of the pointers (in use by the customer since 2007) was found to be bent.If this pointer was used during the surgery for the patient registration to navigation, it may have contributed to an inaccurate registration point acquisition to match the patient anatomy to the preoperative image dataset.User accuracy verification with this damaged pointer also might lead to incorrect results.-- a shift of the navigation reference array (leading to deviation of navigation display of instruments compared to actual patient anatomy) possibly occurred after registration, during the exchange from unsterile to sterile array, or during the surgery, due to one of the hospital's reference array being damaged and might have been used at this surgery.This damaged navigation reference array (in use by the customer since 2010) was found to be no longer rigid as required and allows slight movements of the marker geometry.Apparently the deviation has not been recognized by the user (prior to performing the biopsy) with the necessary continued verification of accuracy throughout the procedure.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.H7: brainlab intends to re-iterate the relevant topics regarding the use of the device to the customer.

Event Description

A cranial surgery for biopsy (diagnostic sample) of a brain tumor was performed with the aid of the brainlab navigation software cranial 2.1.An mri scan was acquired pre-operatively on (b)(6) 2019 to use with navigation.Trajectory and registration points were planned on the scans pre-operatively in the brainlab navigation software the day of the surgery.During the procedure the surgeon: - positioned the patient in a supine orientation in a non-brainlab head holder and attached the unsterile reference array.- performed the initial patient registration on the pre-op mri using the pointer acquiring 10 registration points on the patient's skin to match the display of the navigation to the current patient anatomy.- verified the accuracy of the registration and accepted the registration to proceed.- updated the planned entry point of the pre-planned trajectory using the pointer and the aid of navigation.- removed the unsterile navigation reference array and draped the patient.- attached a sterile reference array, re-verified navigation accuracy, and determined the burr hole placement with the aid of navigation.- attached and aligned the varioguide to the planned trajectory.- used the brainlab distributed (pajunk) biopsy needle inserted to the varioguide to collect tissue samples, which were sent to pathology for diagnosis.- completed the surgery.The tissue collected was determined to be non-diagnostic by pathology.A post-operative ct showed there was a 1cm deviation medially from the intended and planned target.The entry point was in the intended location.A revision surgery is planned but has not yet occurred.According to the surgeon: - there was no (direct or increased) risk to harm a critical brain structure (e.G.Blood vessels or important brain tissue) due to an actual biopsy resection or path actually applied.- there were no negative clinical effects for this patient, and there was no prolongation of surgery / anesthesia.- a revision surgery is planned to retrieve a diagnostic sample but has not yet occurred.- there are no (other) remedial actions necessary, done or planned for this patient.- there is a planned prolong of hospitalization only for the planned revision surgery.

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 2.1)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 8704048
• MDR Text Key: 148177065
• Report Number: 8043933-2019-00033
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481000493
• UDI-Public: 04056481000493
• Combination Product (y/n): N
• PMA/PMN Number: K092467
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22214-02D
• Device Catalogue Number: 71096
• Device Lot Number: SW V. 2.1.2
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other