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

Model Number	9735560
Medical Device Problem Codes	Thermal Decomposition of Device (1071); No Display/Image (1183); Environmental Compatibility Problem (2929)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a thermal therapy system being used during a soft tissue ablation (neuro) procedure.It was reported that after the case, there were traces of blood found in the cooling liquid inside the catheter and where they connect to the catheter.The ablation was done on a big cavernoma, rendering the inside of the cavernoma very noisy and hard to interpret the temperature mapping.Although advised to stay below 75% of laser power, the surgeon decided to go higher to reach more of the border of the cavernoma.Due to the traces of blood, it was suspected that the catheter was burned, allowing blood to enter.Since the case was finished, no further action was taken.During the case, no obvious indication of a leaking catheter was detected.The post-operative 3d images did not show any obvious edema.There was no reported delay to the procedure due to this issue.There was no reported impact on patient outcome.
Additional Manufacturer Narrative
H3, h6: no products have been returned to medtronic for analysis, but the product was discarded.Codes b18, c20, and d15 are applicable.Multiple fdd/annex a codes were reported.A19 was coded for blood found in the catheter.A1006 was coded for suspected burned catheter.A090206 was coded for the noisy and hard to interpret temperature map (tmap.) medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: VISUALASE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21360517
• Report Number: 1723170-2025-00631
• Device Sequence Number: 15566348
• Product Code: GEX
• UDI-Device Identifier: 00763000416430
• UDI-Public: 00763000416430
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K053087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/11/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2026
• Device Model Number: 9735560
• Device Catalogue Number: 9735560
• Device Lot Number: 0229594986
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male