MAUDE Adverse Event Report: MEDTRONIC XOMED INC. VISUALASE; POWERED LASER SURGICAL INSTRUMENT

Model Number	9735560
Medical Device Problem Codes	Mechanical Problem (1384); Biocompatibility (2886)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
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 when starting the saline pump for the first laser (right side) they noticed noisy artifact on the temperature map (tmap) imaging.They noticed saline had not made it back to the return bag.They checked for leaks near the bolt cap or anywhere near the catheters, there were no leaks visible.The medtronic rep expressed concern to surgeon.They ran t1 t2 3d imaging scans.It seemed like the artifact was air.It was noted that the 2 lasers used were daisy chained together.The surgeon decided to proceed with the second laser (left side) and changed the tubing connection to just flow to the second catheter (left).They proceeded with no complications.At the end of the case, upon removal of the right catheter, it was noted that the tip of the catheter was bent.The rep pressure tested it with saline, saline leaked at the tip and nothing would enter the return line of catheter.It was noted that there was a bend near the 95mm mark on the catheter.That happened after transporting patient out of mri.It had nothing to do with why the tip was bent/broken, the catheter was not bent at that mark when issue occurred.There was an unknown impact to the patient's outcome.There was a delay of less than one hour.It was reported that the ablation of the affected side took place 2 days later (on the wednesday).The patient was admitted to the icu for monitoring.The second procedure went smoothly and there was no additional impact on the patient's outcome.
Additional Manufacturer Narrative
H3/h6: the catheter was returned for analysis.The tip of the returned catheter had been broken.This allowed the reported leak.Codes b01, c07, and d02 apply.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 XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22069759
• Report Number: 1045254-2025-01381
• Device Sequence Number: 15793533
• Product Code: GEX
• UDI-Device Identifier: 00763000416430
• UDI-Public: 00763000416430
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2025

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: 09/17/2026
• Device Model Number: 9735560
• Device Catalogue Number: 9735560
• Device Lot Number: 0229699597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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: 37 YR
• Patient Sex: Male
• Patient Weight: 99 KG