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

Model Number 22214C

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Human Factors Issue (2948); Device Handling Problem (3265)

Patient Problem Pulmonary Embolism (1498)

Event Date 06/22/2017

Event Type  malfunction  

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 according to the surgeon: - the aim of the surgery to reduce the hematoma to a rest of 10 cm³ was not fully achieved.- aspiration of brain tissue occurred at 1st and 2nd aspiration, it is unknown if the brain tissue was anyways present within the hematoma to aspire.- despite there was no direct or increased risk to harm a critical structure due to the catheter placements.- the delay of anesthesia was ca.12h, also due to re-sterilization, with the patient waiting in the icu.- lung embolism occurred (suspected related to anesthesia time): the patient complained about breathing difficulty.After obtaining ct chest, and confirming the embolism with beginning lung infarction, patient obtained anticoagulation via heparin.A full anticoagulation was not possible due to the primary brain hemorrhage.The sequelae for the future are still too early to define.- the planned drug delivery into the brain after the drainage could not be given to this patient.- despite there are no further negative effects to the patient reported, nor further remedial actions.- despite hospitalization of the patient did not need to be prolonged due to this issue.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 registration points acquired by the user during surface matching to register the anatomy to the ct were not adequately and sufficiently distributed at all registrations, as required by the navigation software.- the 2nd catheter placement was free-hand with only using a navigated pointer to orientate.Further contributing factors: - the marker spheres used for the unsterile instruments were not new / unused as required.- a movement of the navigation reference array or the patient's head in the head holder might have occurred.- a shift of the brain (patient anatomy) in comparison to the ct scan due to the procedure might have contributed especially since the duration of the surgery was extended by a significant number of hours.- a shift of the entry point during drilling might have occurred for the 3rd catheter placement attempt and not recognized, despite navigation shows the alignment of the biopsy needle relative to the trajectory (including entry point) to the user.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, due to non-ideal verification technique.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 (basal ganglia), with a size of ca.43 cm³, was performed with the aid of the brainlab cranial navigation system version 2.1.2.A pre-operative ct scan was acquired one day before the surgery to use with navigation.A trajectory for catheter placement was planned using this pre-op ct scan.During the procedure the surgeon: - positioned the patient in a supine position in a non-brainlab head holder.- performed the initial patient registration on the pre-op ct with registration points taken on the skin of the patient (face and forehead) to match the virtual display of the navigation to the current patient anatomy.- verified the accuracy of the registration on the patient's skin to be acceptable for use.- draped the patient, performed the craniotomy (burrhole), aligned a navigated biopsy needle used as guidance for the catheter and placed the catheter for drainage.- a post-op ct scan was performed, and showed that the catheter was not ideally placed.The catheter deviated by ca.6 mm from the intended target point, still drainage of blood was possible with this placement, with aspiration of ca.20 cm³.- performed a second attempt of catheter placement, with a new patient registration to navigation and using a navigated pointer to orientate for the free-hand catheter placement.The craniotomy (burrhole) was not changed.- the second post-op ct scan showed that the catheter deviated by ca.1 cm from the intended target point, further aspiration of ca.10 cm³ was possible.- performed a 3rd attempt of catheter placement, with a new trajectory planned and change of the craniotomy (burrhole), again with a new registration and with a navigated biopsy needle used as guidance for the catheter.- the 3rd post-op ct scan showed that the catheter deviated also by ca.1 cm from the intended target point, further aspiration of ca.9 cm³ was possible.According to the surgeon (retrieved from surgeon on 6 july 2017 and further clarification on 10 july 2017): - the aim of the surgery to reduce the hematoma to a rest of 10 cm³ was not fully achieved.- aspiration of brain tissue occurred at 1st and 2nd aspiration, it is unknown if the brain tissue was anyways present within the hematoma to aspire.- there was no direct or increased risk to harm a critical structure due to the catheter placements.- the delay of anesthesia was ca.12h, also due to re-sterilization, with the patient waiting in the icu.- lung embolism occurred (suspected related to anesthesia time): the patient complained about breathing difficulty.After obtaining ct chest, and confirming the embolism with beginning lung infarction, patient obtained anticoagulation via heparin.A full anticoagulation was not possible due to the primary brain hemorrhage.The sequelae for the future are still too early to define.- the planned drug delivery into the brain after the drainage could not be given to this patient.- there are no further negative effects to the patient reported, nor further remedial actions.- hospitalization of the patient did not need to be prolonged due to this issue.

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 2.1.2)
• 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: 6716586
• MDR Text Key: 80141885
• Report Number: 8043933-2017-00019
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481000493
• UDI-Public: 04056481000493
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 22214C
• Device Catalogue Number: 71208
• Device Lot Number: SW V.2.1.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/23/2017
• Initial Date FDA Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2015
• 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; Required Intervention