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

Model Number ILS-1000-CS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pneumothorax (2012)

Event Date 07/21/2022

Event Type  Injury  

Event Description

According to the literature source of study performed on september 2020 through november 2021, a retrospective study analyzed the impact of fluoroscopic navigation, digital tomosynthesis, and continuous catheter tip tracking on diagnostic yield of small, bronchus sign negative lung nodules.A total of 144 patients underwent the procedure during the study period, with 159 nodules biopsied.Pneumothorax occurred in 1 (0.7%) patient, with that patient requiring chest tube insertion, which was removed within 24 hours.No evidence of bleeding requiring intervention other than suctioning occurred.Five patients were admitted overnight post-procedure for additional monitoring due to hypoxemia.All patients were already on supplemental oxygen at baseline (range 2-4l), returned to baseline oxygen requirements within 24 hours, and were subsequently discharged.

Manufacturer Narrative

Pneumothorax is a known short-term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.Title: size and vision: impact of fluoroscopic navigation, digital tomosynthesis, and continuous catheter tip tracking on diagnostic yield of small, bronchus sign negative lung nodules article: medical college of wisconsin, respiratory medicine, journal homepage: www.Elsevier.Com/locate/rmed, https://doi.Org/10.1016/j.Rmed.2022.106941 accepted 21 july 2022 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ILLUMISITE
• Type of Device: 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15420890
• MDR Text Key: 299927976
• Report Number: 3004962788-2022-00075
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 10884521723634
• UDI-Public: 10884521723634
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ILS-1000-CS
• Device Catalogue Number: ILS-1000-CS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR