MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 3.5); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 26615-01A

Device Problems Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problems Paresis (1998); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/09/2021

Event Type  Injury  

Manufacturer Narrative

Outcomes attributed to adverse event: a risk to the patient's health could not be excluded for these specific circumstances, since instrument paths were applied in a different location in the brain than anticipated with the brainlab device involved, negative clinical effects did occur for this patient according to the surgeon, and a second surgery was required to successfully complete the procedure as intended: despite the revision surgery was completed successfully using brainlab navigation despite there was no negative clinical effect to the patient from the prolongation of anesthesia (of 30 minutes) during the initial surgery, nor for the revision surgery/anesthesia of 60 minutes despite there were no further medical/surgical remedial actions necessary, done, or planned for this patient the outcome of the initial surgery was considered poor and the patient presented with hemiparesis and dysplasia after the initial surgery, which are reversible and improving slowly according to the surgeon.The surgeon attributed these negative effects to placing the shunt without the use of navigation.Hospitalization was prolonged by 14 days.Adverse event problems: 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 initially unsuccessful placement attempts of the vp shunt and reported 10mm deviation for this procedure using navigation was a combination of one or more of the following factors: an insufficient distribution of points acquired by the user for patient anatomy registration to navigation, in combination with an inadequate patient scan used for registration, both not following brainlab requirements.Specifically, the overall point acquisition was not sufficiently widely and evenly distributed over the required patient skin surface, including right and left sides of the patient's face and unique bony areas such as the entire/both sides of the nose.Additionally, the preoperative patient ct scan used for patient registration did not include the entire face, (including the entire nose) and also included the headrest on the patient's left side and back of the head, leading to unavailability of these necessary areas for registration point acquisition.This insufficient distribution of registration points caused the cranial navigation software to not find an as accurate match in the region of interest as desired for this specific procedure in between the preoperative image dataset and the actual patient anatomy.Movement of the patient's head in the non-brainlab head holder and/or the navigation reference array, due to insufficient rigid fixation and/or inadvertent forces, might have occurred after draping and before the incision was made.Relative movements between the reference array and the patient's head after registration cannot be compensated by the navigation.A damaged 4-sphere reference array typically used by this customer for the unsterile (registration) portion of the procedure, which may have been used at this specific surgery, was found to have a bent marker post the day after the surgery.(the damage occurred during use at the user facility, after handover to the user, e.G.Due to improper handling and/or long-term use.) the use of a damaged reference array for registration can result in a deviation of the display of the navigation compared to the actual position of the patient's anatomy after the (damaged) unsterile reference array used for registration is removed and the separate (undamaged) sterile reference array used for surgery is attached.The navigation software relies on the recognition of an exact same position and geometry of the (sterile) navigation reference array in relation to the patient anatomy as it was during registration to navigation, based on the pre-operative scan to the current patient anatomy, throughout the complete use of navigation during a surgery, in order to accurately track navigated instruments.Apparently the resulting deviation of the navigation display was not recognized by the user with the required thorough verification of the registration accuracy, and the necessary continued verification of navigation accuracy after draping, and throughout the procedure (prior to navigating the vp shunt).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.Usage of device: brainlab intends to reiterate the relevant topics regarding the use of the device to this customer.Additionally, the damaged reference array has been removed from clinical use at this customer site.

Event Description

A surgery for placement of a right ventriculoperitoneal (vp) shunt was performed with the aid of the display by the (b)(4).During the procedure the surgeon: planned a trajectory within the brainlab software and loaded the (pre-calibrated) geometry of the brainlab disposable stylet into the navigation software.Positioned the patient in a supine orientation in a non-brainlab head holder.Performed the initial patient registration on the preoperative mri acquiring registration points on the patient's skin to match the display of the navigation to the current patient anatomy, and verified and accepted the accuracy of the registration to proceed.Removed the unsterile navigation reference array, draped the patient, and attached the sterile reference array.Created the bone flap and burr hole to accommodate the shunt, and opened the dura.Updated the entry point of the planned trajectory intraoperatively using the brainlab pointer to better align to the right ventricle.Used the navigated brainlab stylet to place a catheter in the right ventricle, but no cerebrospinal fluid (csf) was returned.A couple further attempts in the same manner were also unsuccessful.Used the navigated brainlab pointer to assess accuracy and determined a deviation in the display of navigation compared to the patient's actual anatomy of approximately 10mm.Ceased the use of navigation and placed the shunt catheter conventionally.It was noted there was low pressure of csf with the final (non-navigated) placement of the shunt catheter.According to the surgeon: the surgery was completed without navigation but with a poor outcome.A revision surgery was required and performed 3 days later with brainlab navigation, which was completed successfully.The patient presented with hemiparesis and dysplasia after the initial surgery, which are reversible and improving slowly, according to the surgeon.The surgeon attributed these negative effects to placing the shunt without the use of navigation.Hospitalization was prolonged by 14 days.There were no (further) medical/surgical remedial actions necessary, done, or planned for the patient.There was no negative effect for the patient from the prolongation of anesthesia (of 30 minutes) during the initial surgery, nor for the revision surgery/anesthesia of 60 minutes.

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 3.5)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer Contact: maura boyle ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 12134767
• MDR Text Key: 264074207
• Report Number: 8043933-2021-00046
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481140663
• UDI-Public: 04056481140663
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K192703
• 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: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 26615-01A
• Device Catalogue Number: 26615-01A
• Device Lot Number: SW V. 3.5.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2021
• 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): Hospitalization; Other