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

Model Number	SDATSW01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	11/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pneumothorax is a known short-term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.D10 concomitant products: ils-0900-kt, ils-0900-kt procedure kit illumisite 90 (lot#dmm03114); ils-1000-cs, ils-1000-cs illumisite console (sn:unknown); cagen1, cagen1 ablation generator x1 (lot#eg20481429); unk emprint ant, unknown emprint antenna (lot#dmm003422).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.
Event or Problem Description
According to the reporter, during the thermoablation procedure, the patient had pneumothorax on the left side.Chest drainage was then performed.Nine days after the procedure, the patient had compressive right pneumothorax post endoscopic thermoablation of bilateral pulmonary metastases from an adenocarcinoma of the upper rectum.Chest tube was used under local anesthesia with immediate bubbling.The patient hospitalization was prolonged as a result.The patient site related assessment indicates that the adverse event was not device related but has probable relation to the study procedure.

• Brand Name: CROSSCOUNTRY
• 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: 19537398
• Report Number: 3004962788-2024-00058
• Device Sequence Number: 12368518
• Product Code: EOQ
• UDI-Device Identifier: 10884521809536
• UDI-Public: 10884521809536
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2024

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: SDATSW01
• Device Catalogue Number: SDATSW01
• Device Lot Number: DMM03253
• 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: 05/17/2024
• Initial Report FDA Received Date: 06/14/2024
• 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 H11
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 85 KG