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

Model Number	9735560
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
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 during a multiple catheter case the system worked as expected for the first three catheters.After switching the saline tubing connection for the next catheters, saline stopped getting pulled out of the bag to circulate through the tubing system.It may have started initially but then stopped.Turned off the pump and tried several troubleshooting attempts on the pump side, including reseating the tubing, changing the short section of the tubing, a new saline bag and a second pump, as this account has an extra one.Saline would not come out of the bag.Made a separate saline circuit with different tubing and a demo catheter and that worked, so that eliminated the pump as a problem.Decided to change the long set of tubing and check if the current tubing was pinched an ywhere.No obvious kinks or pinches in the existing tubing set were observed, but it was replaced, as that has not been tried yet.It took some time to disconnect the tubing.While changing the tubing, the fellow noticed that one of the bolts was a little wobbly.This bolt did not have the best purchase due to the effect of previous surgeries and radiation therapy in that area.Theorized that perhaps the bolt was slightly pinching the catheter, making it difficult for the saline to pass through.After changing the tubing and running a 5 minute scan to confirm that there was no saline leak around the catheter with the wobbly bolt (was not suspected, but wanted to confirm), the system worked as expected for the remainder of the procedure.Unclear if the root problem was the catheter getting pinched by the wobbly bolt or maybe there was something in that tubing set that caused a block.There was a delay of less than 1 hour and no impact on patient outcome.
Additional Manufacturer Narrative
H3: no parts have been received by the manufacturer for evaluation.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.

• 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: 22206497
• Report Number: 1045254-2025-01514
• Device Sequence Number: 6887847
• Product Code: GEX
• UDI-Device Identifier: 00763000416430
• UDI-Public: 00763000416430
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/13/2025

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 Model Number: 9735560
• Device Catalogue Number: 9735560
• Device Lot Number: 0230920455
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 9 YR
• Patient Sex: Female
• Patient Weight: 39 KG