MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC VISUALASE GUIDED LASER ABLATION SYSTEM; LASER INSTRUMENT, SURGICAL, POWERED

Model Number 002-1100

Device Problems Material Fragmentation (1261); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/25/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: the catheter kit was returned to the manufacturer for analysis.It was noted that the fiber was cut off from the kit.The catheter was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.Medical safety assesses the reported event of a patient with a small hemorrhage, following a soft neuro tissue ablation of the frontal lobe (to treat epileptic tuberous sclerosis), involving the use of the visualase® device, and its reported severity (critical), as labeled.In the visualase® cooled laser applicator system (vclas) (9735559, 9735560, and 9735561) instructions for use under adverse events as well as side effects it states, ¿adverse events the visualase® thermal therapy system is a surgical tool.Adverse reactions are consistent with the surgical procedures in which visualase® is used.Side effects potential side effects associated with laser induced thermal therapy (litt), though not necessarily associated with the use of this device, include: minor bleeding, hematoma without neurological compromise, infection, and cerebral edema." if information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that, while in a soft neuro tissue ablation of the frontal love to treat epileptic tuberous sclerosis, the third laser fiber of four placed was noted to have an off behavior in the thermography as head was carried past the tip of the laser fiber.The site then paused, allowed the heat to cool, powered the unit back on and the issue recurred though not to a temperature that would damage healthy tissue.A pullback was performed and found to be okay.After the final laser ablation, post-operative imaging found fluid around the third catheter area.Multiple images found the issue, where a contrasted 3d image found a highlighted area.A diffusion was run and showed potential blood, that was then noted to be a small hemorrhage.The third catheter was noted to not be charred and noted that heat did not manipulate it.Irrigation was pushed through the catheter and a small pinhole had irrigation come out.However, heat was noted to not be suspected as the cause of the hole.The hemorrhage was drained and the patient was required further hospitalization.There was a reported delay to the procedure of less than 1 hour due to this issue.No additional information was provided.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received additional information that it was unknown if the hemorrhage was caused by the leaking catheter.It was noted that saline did leak into the brain.The surgeon reported that the patient is doing good.

Manufacturer Narrative

Further software investigation confirmed that the software was working as designed.It was noted that laser powers and timing recommendations were exceeded.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A software analysis was initiated and found that the software was functioning as designed.However, the software evaluation found that a probable cause was unable to be determined.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VISUALASE GUIDED LASER ABLATION SYSTEM
• Type of Device: LASER INSTRUMENT, SURGICAL, POWERED
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8537947
• MDR Text Key: 142734214
• Report Number: 1723170-2019-01900
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081656
• 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,Followup,Followup,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 002-1100
• Device Catalogue Number: 002-1100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2019
• Initial Date FDA Received: 04/22/2019
• Supplement Dates Manufacturer Received: 06/11/2019; 08/15/2019; 12/12/2019
• Supplement Dates FDA Received: 06/21/2019; 09/06/2019; 01/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2014
• 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): Required Intervention
• Patient Age: 9 YR
• Patient Weight: 32