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

Model Number	AAS00161-20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Additional 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.Electromagnetic navigation bronchoscopy-guided preoperative lung nodule localization in video-assisted thoracic surgery (vats): a learning curve analysis; jinbo zhao; translation lung cancer research 2024;13(10):2561-2572 | https://dx.Doi.Org/10.21037/tlcr-24-337 | published online oct 28, 2024.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.
Event or Problem Description
According to literature, a retrospective study analyzed the learning curve of electromagnetic navigation bronchoscopy (enb) in patients with small peripheral pulmonary nodules between november 2019 and december 2021.Superdimension was used to reconstruct the virtual bronchus reconstruction and identify the pathway to the target lesion.Complications related to the enb procedure included pneumothorax in two patients.Interventions were not reported.

• Brand Name: SUPERDIMENSION
• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21124944
• Report Number: 3004962788-2025-00009
• Device Sequence Number: 20717535
• Product Code: JAK
• UDI-Device Identifier: 10884521199989
• UDI-Public: 10884521199989
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: AAS00161-20
• Device Catalogue Number: AAS00161-20
• 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: 12/18/2024
• Initial Report FDA Received Date: 01/10/2025
• 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: Other
• Patient Age: 54 YR
• Patient Sex: Female