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

Model Number	9735560
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A medical safety review determined that intracranial bleeding and its reported severity are not related to the device or laser ablation therapy, but instead is a known complication associated with navigational inaccuracy observed during the navigated biopsy procedure performed prior to placement of the catheter and with noted blood at the anchor site directly after navigated brain biopsy.F1205: brain bleed f1908: delay of one hour or longer g2: this event occurred in australia, see section e.H3, h6: no products were returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.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.
Event or Problem Description
Medtronic received information regarding a thermal therapy system being used during a catheter placement procedure.It was reported that a bleed in the brain occurred after the visualase cooling laser applicator system (vclas) catheter was placed.The bleed was detected in the magnetic resonance imaging (mri) scanner prior to laser ablation.The surgeon made the decision to abort the laser ablation and do an open craniotomy to fix the bleed and remove the intended lesion.In discussions with the neurosurgeon and neurologist, it was determined that the burr hole for the catheter placement differed from the planned trajectory.This contributed to the biopsy occurring in the incorrect location, likely resulting in a bleed.Blood was seen coming out of the top of the bone anchor, prior to the catheter being placed, indicating that the bleed occurred during the biopsy.It was noted that a possible reason for the inaccuracy of the burr hole placement was that the cosman-roberts-wells (crw) stereotactic head frame had slipped from the planned coordinates.Another possible reason was that the head pins of the frame had slipped from the position they were in during the initial computed tomography (ct) frame registration.There was a delay to the procedure of one hour or longer.Additional information was received stating that it was estimated using the navigation system that the amount of inaccuracy at the point of entry was 4.3 mm.The blue plan was the original planned trajectory and the yellow plan was the inaccurate trajectory.
Additional Manufacturer Narrative
On further review of this event, it has been determined that it is no longer reportable on this system.Please reference regulatory report # 1723170-2025-01814, which documents this event on the navigation system, for further event information.Additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event does not meet the reporting requirements in 21 cfr 803.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: 21927978
• Report Number: 1045254-2025-01230
• Device Sequence Number: 21059660
• Product Code: GEX
• UDI-Device Identifier: 00763000416430
• UDI-Public: 00763000416430
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 05/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9735560
• Device Catalogue Number: 9735560
• Device Lot Number: 0229849859
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male