MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC UNKNOWN CYTOLOGY BRUSH; ENDOSCOPIC CYTOLOGY BRUSH

Model Number UNKNOWN CYTOLOGY BRUSH

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

Patient Problems Pneumothorax (2012); Bronchial Hemorrhage (4456)

Event Date 12/12/2022

Event Type  Injury  

Event Description

According to the literature study, a prospective study evaluated diagnostic yield in patients who underwent electromagnetic navigation bronchoscopy procedures between may 2018 and february 2020.All procedures were performed using the superdimension navigation system 7.1.215 procedures were performed with cytobrushes used in 120 patients.Complications included: pneumothorax and bronchopulmonary hemorrhage.Chest tube insertion was required to treat pneumothorax in two cases and bronchopulmonary hemorrhage required a balloon catheter in one case.Article: when pulmonologists are novice to navigational bronchoscopy, what predicts diagnostic yield? author: kristoffer mazanti cold year: 2022 publication: licensee mdpi.

Manufacturer Narrative

Title: when pulmonologists are novice to navigational bronchoscopy, what predicts diagnostic yield? source: diagnostics 2022, 12, 3127 accepted: 7 december 2022.Concomitant medical product/s: aas00161 aas00161-21 en superd navigation system, serial #:unknown, unknown needle unknown biopsy needle lot #:unk pneumothorax is a known short-term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.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: UNKNOWN CYTOLOGY BRUSH
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• 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: 16496582
• MDR Text Key: 310809304
• Report Number: 3004962788-2023-00033
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2023

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
• Device Operator: Health Professional
• Device Model Number: UNKNOWN CYTOLOGY BRUSH
• Device Catalogue Number: UNKNOWN CYTOLOGY BRUSH
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2023
• Initial Date FDA Received: 03/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention