MAUDE Adverse Event Report: ILLUMISITE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	ILS-0450-KT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	06/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title: sight unseen: diagnostic yield and safety outcomes of a novel multimodality navigation bronchoscopy platform with real-time target acquisition source: interventional pulmonology published online: september 3, 2021 pneumothorax is a known short-term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the literature, this study aimed to assess a vanderbilt university of patients undergoing electromagnetic navigation br onchoscopy to aid in the diagnosis of peripheral lung lesions.100 lung lesions were sampled in 82 patients.A th-190 therapeutic bronchoscope (olympus america© [center valley, pa, usa]) was used for every procedure.After the airway examination was completed, the preselected illumisite extended working channel (ewc) with a locatable guide (lg) was introduced into the working channel.Registration was completed, and peripheral navigation was commenced.Pneumothorax: three (3) pneumothoraces were identified in the immediate postprocedure phase and required management with a chest tube.Bleeding: bleeding requiring intervention in 2 patients (defined as grade 2¿4 of the nashville working group scale) was noted.There were no procedure-related hospital admissions.Oxygen support needed: five percent of patients required temporary supplemental oxygen support.This was defined as a de novo need for supplemental oxygen or an increase in their previously prescribed ambulatory supply.Ewc-lg uncoupling: ¿although uncommon, we experienced a handful of electronic ewc-lg uncoupling instances, even though their physical connection was maintained.This was a rare occurrence and was not tracked in the database.

• Brand Name: ILLUMISITE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• MDR Report Key: 12518075
• Report Number: 3004962788-2021-00085
• Device Sequence Number: 4290961
• Product Code: JAK
• UDI-Device Identifier: 10884521723832
• UDI-Public: 10884521723832
• Combination Product (Y/N): N
• 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: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2021

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: ILS-0450-KT
• Device Catalogue Number: ILS-0450-KT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 09/23/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention