MAUDE Adverse Event Report: SUPERDIMENSION; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	AAS00161-20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	11/30/2020
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.Title: electromagnetic navigation bronchoscopy combined endobronchial ultrasound in the diagnosis of lung nodules source: medicine (2021) 100:3 accepted: 30 november 2020.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the literature source of study, the applicability of enb combined radial endobronchial ultrasound in the diagnosis of lung nodules with different densities was explored between.Patients who underwent biopsy from 2016-09 to 2019-03 were divided into 2 groups: the solid nodule group and the subsolid pulmonary nodule group.A total of 37 lesions in 25 patients were biopsied, 14 lesions were subsolid pulmonary nodules and 23 were solid nodules.Pneumothorax occurred in 1 case (1/37, 2.7%).In this patient, the lesion was adjacent to the pleura and diaphragm, which suggests a relative contraindication of ptlb (percutaneous lung biopsy).The thoracic pleura was punctured because of unsatisfactory depth control during the biopsy.Closed thoracic drainage was performed immediately.One day after the operation, the patient recovered and was discharged from the hospital.

• Brand Name: SUPERDIMENSION
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• MDR Report Key: 12475844
• Report Number: 3004962788-2021-00080
• Device Sequence Number: 17057701
• Product Code: JAK
• UDI-Device Identifier: 10884521199989
• UDI-Public: 10884521199989
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/15/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: AAS00161-20
• Device Catalogue Number: AAS00161-20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 09/15/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other