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

Model Number AAS00161-36

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Hemorrhage/Bleeding (1888); Pneumothorax (2012); Chronic Obstructive Pulmonary Disease (COPD) (2237)

Event Date 06/16/2020

Event Type  Injury  

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.Bleeding is a known short-term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.Title: cone-beam ct image guidance with and without electromagnetic navigation bronchoscopy for biopsy of peripheral pulmonary lesions source: bronchol intervent pulmonol 2021;28:60¿69.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study, an assessment was performed whether cone-beam computed tomography (cbct) imaging can improve navigation and diagnosis of peripheral lesions by 2 clinical workflows with a cross-over design: (1) a primary cbct and radial endobronchial ultrasound mini probe imaging¿based approach and (2) a primary electromagnetic navigation (emn) and radial endobronchial ultrasound mini probe imaging¿based approach.Eighty-seven patients with 107 lesions were included and randomly assigned to study arms.Observed complications across both study arms were as follows; pneumothorax (n=3), copd exacerbation following the procedure (n=1), moderate bleeding intraprocedurally following cryobiopsy (n=1), and minor fever ( <(><<)> 4h, n=1).All study subjects¿except 1 having pneumothorax requiring chest tube and 1 case of copd exacerbation¿were able to return home the same day.

• Brand Name: SUPERDIMENSION
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• MDR Report Key: 12434756
• MDR Text Key: 270181741
• Report Number: 3004962788-2021-00072
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AAS00161-36
• Device Catalogue Number: AAS00161-36
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other