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

Model Number 22216-01A

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Paralysis (1997); Dysphasia (2195); Blood Loss (2597)

Event Date 05/29/2020

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since the craniotomy deviated from the desired location (and needed to be extended for surgery to be effective as intended) with the brainlab device (navigation) involved, and there were negative clinical effects for the patient, according to the surgeon: despite the avm was successfully removed during the surgery.The patient experienced intensive bleeding during the surgery as a result of the deviation of the craniotomy; the bleeding required intervention by the surgeon, and was successfully stopped during the surgery.There was a prolongation of anesthesia by 90 minutes due to the issue with navigation.The patient was hemiplegic and aphasic following the surgery.The surgeon's opinion is that the damage to the patient was due to a number of reasons including the issue with navigation.The patient's hemiplegia and aphasia have improved only a small amount since the surgery, and the surgeon expects some permanent damage.Hospitalization was prolonged by 2 additional weeks in the icu, and another 2 weeks of hospitalization is planned for this patient.There are no further remedial actions necessary, done, or planned for this patient.According to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the root cause of the deviation of the craniotomy from the intended location by approximately 40 mm and requiring an extension of approximately 40 mm, is due to a movement of the navigation reference array relative to the patient's head and/or movement of the patient's head within the head holder pins after registration from inadvertently applied forces during the procedure (e.G.During draping, during exchange of unsterile to sterile array, due to accidental bumping into array, etc.).Relative movements of the patient's head within the head holder and reference array cannot be compensated by the brainlab cranial navigation system.Potential contributing factors include a suboptimal quality patient scan used for surface matching registration which did not completely fulfill brainlab's requirements (distortion and artifacts were present) and a suboptimal distribution of points acquired during registration with points not acquired as necessary e.G.Points were taken on or near scan areas that contained distortion and points were not evenly distributed across both sides of the patient's face and nose.Both factors can cause the brainlab cranial navigation software to not find an as accurate match as desired in between the pre-operative image dataset and the actual patient, for the procedure to be performed.It is critical that the registration accuracy is carefully verified before accepting it to proceed with navigation and that sufficient accuracy is maintained throughout the procedure.Apparently, the navigation inaccuracy was not recognized or detected by the surgeon during the verification step of the registration and/or prior to performing the craniotomy with the necessary and appropriate accuracy verification checks.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 reiterate the relevant topics regarding the use of the device to this customer.

Event Description

A cranial surgery for resection of an arteriovenous malformation (avm) located near the left rolandic fissure, was performed with the aid of the display by the brainlab navigation software cranial 3.1.A preoperative mri scan was acquired five days prior to the surgery, to use with navigation.During the procedure the surgeon: positioned the patient in supine position in a non-brainlab headholder.Performed the initial patient registration on the preoperative mri using the z-touch acquiring 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.Planned the craniotomy with the aid of navigation in the unsterile environment.Removed the unsterile navigation reference array, draped the patient, and attached he sterile reference array.Performed the craniotomy (7 x 7 cm) and removed the bone flap.Detected a deviation in the display of navigation compared to the patient's anatomy: the craniotomy was not located over the avm as intended, deviating by approximately 40mm.There was intensive bleeding from the craniotomy due to its location closer to the sagittal sinus than planned.Stopped the bleeding and extended the craniotomy by approximately 4cm.Completed the surgery using conventional methods, without navigation.According to the surgeon: the avm was successfully removed during the surgery.The patient experienced intensive bleeding during the surgery as a result of the deviation of the craniotomy from the intended position by approximately 40mm; the bleeding required intervention by the surgeon, and was successfully stopped during the surgery.There was a prolongation of anesthesia by 90 minutes due to the issue with navigation.The patient was hemiplegic and aphasic following the surgery.The surgeon's opinion is that the damage to the patient was due to a number of reasons including the issue with navigation.The patient's hemiplegia and aphasia have improved only a small amount since the surgery, and the surgeon expects some permanent damage.Hospitalization was prolonged by 2 additional weeks in the icu, and another 2 weeks of hospitalization is planned for this patient.There are no further remedial actions necessary, done, or planned for this patient.

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 3.1)
• 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: 10200422
• MDR Text Key: 202860824
• Report Number: 8043933-2020-00029
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481000479
• UDI-Public: 04056481000479
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22216-01A
• Device Catalogue Number: 71201A
• Device Lot Number: SW V.3.1.4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• 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): Hospitalization; Required Intervention; Disability