MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC ILLUMISITE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	ILS-1000-CS
Medical Device Problem Codes	Failure to Advance (2524); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, when a physician went to perform automatic registration, the first catheter went between the error messages of the navigation catheter out of sensing volume and not coupled.The surgeon replaced the cables and the patient's position was checked, but the same issue occurred.Another catheter was then used.Later in the procedure, after navigation and biopsies, the icon began jumping and, eventually, an error of replaced locatable guide (lg) appeared.Additionally, the catheter was broken.The catheter was replaced again, resolving the issue.The physician was able to complete the superdimension portion of the case.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
D10.Concomitant products: ils-0900-kt, ils-0900-kt procedure kit illumisite 90 (lot 530978); unk - ils, unknown interv.Lung solutions product (lot unknown).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
It was reported that during a procedure, when a physician went to perform automatic registration, the first catheter went between the error messages of the navigation catheter out of sensing volume and not coupled.  the surgeon replaced the cables and the patient's position was checked, but the same issue occurred.Another catheter was then used.Later in the procedure, after navigation and biopsies, the catheter was not coupling, eventually, an error of replaced locatable guide (lg) appeared.Additionally, the catheter was broken.The catheter was replaced again, resolving the issue.The physician was able to complete the superdimension portion of the case. no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: b5, d4 (serial number, udi #), d10, g3, h4 d10.Concomitant products: ils-0900-kt, ils-0900-kt procedure kit illumisite 90 (lot 530978); ils-0900-kt, ils-0900-kt procedure kit illumisite 90 (lot 530978).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: ILLUMISITE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer (Section G): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22561557
• Report Number: 3004962788-2025-00084
• Device Sequence Number: 9220227
• Product Code: JAK
• UDI-Device Identifier: 10884521723634
• UDI-Public: (01)10884521723634(11)191021
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K191394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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: ILS-1000-CS
• Device Catalogue Number: ILS-1000-CS
• 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: 07/17/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/26/2025
• Date Device Manufactured: 10/21/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female