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

Model Number	SDGN447
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Pneumothorax (2012); Blood Loss (2597)
Date of Event	07/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title improved respiratory motion tracking through a novel fiducial marker placement guidance system during electromagnetic navigational bronchoscopy (enb) source radiation oncology, volume 14, 2019 (1-8) article number: 24 date of publication: 11-jul-2019.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the literature source of study performed to patients who received robotic sabr for lung tumors from may 2015 until january 2017, all patients used superdimension.A total of 128 patients with 147 treated lung lesions were identified.Enb using the superdimension was used to guide fiducial marker placement with and without the superdimension fiducial wizard tool.Patients in whom the superdimension fiducial wizard tool are called the ¿fpgs group¿ and patients in whom superdimension was used without the fiducial wizard tool are called ¿non-fpgs group¿.Complications for fiducials placed in lesions that used the fpgs (n = 44) included pneumothorax (2.27%) and bleeding (2.27%), ctcae grade i and ii, respectively.For the lesions that did not utilize the fpgs (n = 103), complications included one incidence of grade ii pneumothorax (0.97%).The non-fpgs cohort did also have two incidences of hypoxia and one of hypotension.It will be noted that the two that developed a pneumothorax were undergoing concurrent biopsy and fiducial placement.

• Brand Name: SUPERLOCK
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• MDR Report Key: 8931895
• Report Number: 3004962788-2019-00062
• Device Sequence Number: 2206617
• Product Code: JAK
• UDI-Device Identifier: 10884521539709
• UDI-Public: 10884521539709
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/26/2019

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: SDGN447
• Device Catalogue Number: SDGN447
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 08/26/2019
• 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