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

Model Number	SD180EWCTE-FT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pneumothorax (2012); Respiratory Failure (2484); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the literature, a retrospective study compared the diagnostic yield of electromagnetic navigation bronchoscopy (enb) and shape-sensing robotic-assisted bronchoscopy (ssrab)-guided cone-beam computed tomography cbct.A total of 92 patients underwent enb-cbct and 93 patients underwent ssrab-cbct for biopsy of pulmonary nodules between july 2020 and may 2023.Superdimension was used in the enb group with an extended working channel catheter.The needle or a competitor device was used for fine needle aspiration, followed by a competitor biopsy forceps and cytology brush to acquire tissue.All patients underwent endobronchial ultrasound (ebus)-guided transbronchial needle aspiration for mediastinal staging following navigational bronchoscopy.Complications included:  pneumothorax in 2(2.1%) patients, one patient had hypoxic respiratory failure and two (2.1%) patients had hemodynamic instability.Interventions were not reported.Cone-beam computed tomography-guided shape-sensing robotic bronchoscopy vs.Electromagnetic navigation bronchoscopy for pulmonary nodules 10.21037/jtd-24-178.
Additional Manufacturer Narrative
D10.Concomitant products: unk needle, unknown biopsy needle (lot#unknown); sd90ewcte-ft, sd90ewcte-ft extend work channel 90ft (serial#unknown); ils-1000-cs, ils-1000-cs illumisite console (serial#unknown) ramsy abdelghani, diana espinoza, juan p.Uribe, david becnel, rachel herr, regina villalobos, and fayez kheir."cone-beam computed tomography-guided shape-sensing robotic bronchoscopy vs.Electromagnetic navigation bronchoscopy for pulmonary nodules".Journal of thoracic disease, vol 16, no 9 september 2024.Https://dx.Doi.Org/10.21037/jtd-24-178.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: EDGE
• 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: 20801291
• Report Number: 3004962788-2024-00141
• Device Sequence Number: 12453537
• Product Code: JAK
• UDI-Device Identifier: 10884521199491
• UDI-Public: 10884521199491
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K151376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2024

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: SD180EWCTE-FT
• Device Catalogue Number: SD180EWCTE-FT
• 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: 11/12/2024
• Initial Report FDA Received Date: 11/27/2024
• 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: Other
• Patient Age: 68 YR
• Patient Sex: Male