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

Model Number	ILS-2100-PN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Hypoxia (1918); Pneumothorax (2012)
Date of Event	05/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the literature, a retrospective study examined 200 consecutive patients referred for cone beam ct bronchoscopic biopsy of peripheral lung lesions between april 2021 and november 2021.The company's catheter were used in the first 85 patients and a competitor device was used in the next 115 patients.The biopsy approach included an extended multimodality approach, including in order the following: fine needle aspirate for 8 passes using the company's pulmonary needle or a competitor needle, cytology brush using the company's cytology brush, transbronchial forceps biopsies were performed using the company's forceps or a competitor device.Postoperative complications included pneumothorax in three patients and bleeding in one patient.A chest tube was required to treat pneumothorax in two patients.The patient with bleeding developed postoperative hypoxemia and required over-night hospitalization.The patient also required topical traxemenic acid and topical epinephrine.
Additional Manufacturer Narrative
D10 concomitant: pneumothorax is a known short-term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.Krish bhadra, randolph m.Setser, william condra, brittany amento bader and stephanie david.A cone beam ct bronchoscopy study of the ultrathin cryoprobe for biopsy of peripheral lung lesions.J bronchol intervent pulmonol, volume 31.Doi: 10.1097/lbr.0000000000000936.Pages 117-125.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: 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19549116
• Report Number: 3004962788-2024-00068
• Device Sequence Number: 15132631
• Product Code: EOQ
• UDI-Device Identifier: 10884521809505
• UDI-Public: 10884521809505
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/17/2024

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: ILS-2100-PN
• Device Catalogue Number: ILS-2100-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: 06/13/2024
• Initial Report FDA Received Date: 06/17/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE NOTE ON H11
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention; Other
• Patient Sex: Unknown