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

Model Number	9735560
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the catheter was returned to the manufacturer for analysis.Analysis found that the catheter had a burnt tip.Analysis found that the reported event was related to an mechanical issue.H6: fdm b01, fdr c07, and fdc d02 are applicable to the hardware analysis.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
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 the pump was only working in the extremes.It was set to low and did not allow water out, or high and too much fluid.It seemed that the low flow of fluid resulted in two melted catheters.During the ablation the surgeon noticed it heating up too quickly, and there was no saline return.Upon setup and prior to the laser being turned on, there was saline return.The surgeon examined the 10mm laser fiber and found that the tip had melted.The surgeon performed a test dose at 30%, and then went up to 65%.The surgeon then placed a second 10mm catheter and completed the ablation.At the end of the case, the surgeon noticed a small amount of blood in the saline tubing on the catheter and found that the tip of that catheter had a small amount of charring.The tip had also melted.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no reported impact on patient outcome.

• 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: 21596383
• Report Number: 1723170-2025-01298
• Device Sequence Number: 18225616
• Product Code: GEX
• UDI-Device Identifier: 00763000416430
• UDI-Public: 00763000416430
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K053087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2025

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: 01/09/2026
• Device Model Number: 9735560
• Device Catalogue Number: 9735560
• Device Lot Number: 0228065152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• 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 Age: 58 YR
• Patient Sex: Female
• Patient Weight: 90 KG