MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC ARCPOINT; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	ILS-1800-PN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the literature source of study performed between december 2019 and february 2020, a retrospective study analyzed outcomes of patients who underwent electromagnetic navigational bronchoscopy utilizing superdimension 7.2 for the evaluation of peripheral pulmonary nodules between december 2019 and february 2020.Each patient had 7 fine needle aspirations with the arcpoint 18-gauge needle and 7 forceps samples collected with the superdimension biopsy forceps.There were 72 patients in the study, 56 received moderate sedation and 16 received general anesthesia.For samples deemed to have a nonspecific diagnosis, or pathologic finding of acute inflammation was identified and repeat ct scan of the chest demonstrated a resolved abnormality, or had fluoroscopy navigation failure, these biopsies were calculated as nondiagnostic.Complications in the moderate sedation group included 2 pneumothorax, which did not require chest tube insertion.No complications occurred in the general anesthesia group.There was one fluoroscopy navigation failure in the moderate sedation group (samples taken but no diagnosis obtained).This could partially be because of the inability to perform a breath hold during local registration in patients who had moderate sedation.No complications were related to superlock fiducial markers.Article: evaluation of electromagnetic navigational bronchoscopy using tomosynthesis-assisted visualization, intraprocedural positional correction and continuous guidance for evaluation of peripheral pulmonary; dr.Bryan dunn, 2022, journal of bronchology & interventional pulmonology.
Additional Manufacturer Narrative
Title: evaluation of electromagnetic navigational bronchoscopy using tomosynthesis-assisted visualization, intraprocedural positional correction and continuous guidance for evaluation of peripheral pulmonary nodules source: j bronchol intervent pulmonol volume 00, number 00 2022 accepted: february 1, 2022 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.

• Brand Name: ARCPOINT
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• 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: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 14250554
• Report Number: 3004962788-2022-00033
• Device Sequence Number: 4736356
• Product Code: EOQ
• UDI-Device Identifier: 10884521723627
• UDI-Public: 10884521723627
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K163537
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2022

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-1800-PN
• Device Catalogue Number: ILS-1800-PN
• 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: 04/12/2022
• Initial Report FDA Received Date: 04/29/2022
• 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: Required Intervention
• Patient Sex: Unknown