MAUDE Adverse Event Report: BRAINLAB AG NAVIGATION SOFTWARE CRANIAL EM (VERSION 1.1); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 22240-06C

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2019

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since catheters were applied in a different location in the brain than intended, with the brainlab device involved, despite according to the surgeon: the final outcome after the repeated surgery (on the same day) was successful as intended.There was no (direct or increased) risk to harm a critical brain structure (e.G.Blood vessels or important brain tissue), neither due to the craniotomy or invasive steps, nor due to the (unsuccessful) catheter placement attempts.There was no harm or negative effect to the patient due to this issue, nor due to prolong of surgery/anesthesia (of ca.3 hrs).There are no further remedial actions necessary, done or planned for this patient.There was no prolong of hospitalization either.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 actual trajectories applied, compared to the planned trajectory displayed by the navigation, by ca.1.3 - 2cm is a likely movement of the em patient reference relative to patient anatomy due to forces applied during the user's patient preparation and draping procedure, not following the brainlab recommendations as required when using the em patient reference to only perform patient registration in the sterile environment after the draping procedure has been completed.Apparently the deviation has not been recognized (prior to placing the shunt catheter) by the user 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.Brainlab intends to reiterate the relevant topics regarding the use of the device to this customer.

Event Description

What is the issue? a cranial surgery for placement of a ventriculoperitoneal (vp) shunt catheter for csf drainage was performed with the aid of the display by the brainlab navigation software cranial em 1.1.During the procedure the surgeon: positioned the patient in supine position on the or table.Performed an intraoperative ct scan and planned a trajectory.Attached the non-invasive em reference to the patient's forehead.Performed the initial patient registration on the intraoperative ct scan using the em registration pointer 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 at several anatomical landmarks, judged it as very good, and accepted the registration to proceed.Draped the patient and performed the craniotomy.Inserted the catheter with the aid of a navigated em stylet aligning to the planned trajectory.Removed the em stylet and observed an initial flow of csf out of the catheter, which quickly slowed and ceased.Repeated the two above steps several times with the same result.Performed an intraoperative ct scan and determined the catheter tip was located ca.2cm superior to the ventricle.Repeated the attempts to place the catheter using the navigated em stylet with the same result.Performed another intraoperative ct scan and determined the catheter tip was still located superior to the ventricle.The surgeon took the patient to the radiology department to acquire an additional ct scan and returned the patient to surgery to perform a repeat of the procedure (without brainlab navigation) on the same day, during which the catheter was placed successfully as intended into the ventricle.According to the surgeon: the final outcome after the repeated surgery (on the same day) was successful as intended.There was no (direct or increased) risk to harm a critical brain structure (e.G.Blood vessels or important brain tissue), neither due to the craniotomy or invasive steps, nor due to the (unsuccessful) catheter placement attempts.There was no harm or negative effect to the patient due to this issue, nor due to prolong of surgery/anesthesia (of ca.3 hrs).There are no further remedial actions necessary, done or planned for this patient.There was no prolong of hospitalization either.

• Brand Name: NAVIGATION SOFTWARE CRANIAL EM (VERSION 1.1)
• 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: 8950713
• MDR Text Key: 161190006
• Report Number: 8043933-2019-00040
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481132422
• UDI-Public: 04056481132422
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092467
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22240-06C
• Device Catalogue Number: 22242A
• Device Lot Number: SW V. 1.1.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2018
• 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