MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC CROSS COUNTRY ACCESS TOOL; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	SDATSW01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Pneumothorax (2012)
Date of Event	02/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title: transbronchial microwave ablation of lung nodules with electromagnetic navigation bronchoscopy guidance¿a novel technique and initial experience with 30 cases.Source: transl lung cancer res 2021.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the literature, this study aimed to assess the outcome of transbronchial microwave ablation of lung nodules with electromagnetic navigation bronchoscopy guidance.Total of 30 lung nodules from 25 patients were treated.Mild immediate or delayed pleuritic chest pain was present in 4 cases (13.3%) and responded to common oral analgesics and did not prolong hospital stay.All 4 of the lesions were close to pleura, and the mechanism of pain could be due to pleural irritation after ablation of peripherally located lung nodules.No referred pain to shoulder due to phrenic nerve injury, or referred pain to arm due to brachial plexus injury occurred.Pneumothorax occurred in 2 cases (6.67%) and both required chest drain insertion.Post ablation reaction including fever occurred in 2 cases (6.67%); while mild hemoptysis was noted in 1 case (3.33%).

• Brand Name: CROSS COUNTRY ACCESS TOOL
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• MDR Report Key: 11900943
• Report Number: 3004962788-2021-00049
• Device Sequence Number: 4420455
• Product Code: EOQ
• UDI-Device Identifier: 10884521539723
• UDI-Public: 10884521539723
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K142934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/28/2021

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: SDATSW01
• Device Catalogue Number: SDATSW01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other