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

Model Number AAS00161-20

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Pneumothorax (2012); Blood Loss (2597)

Event Date 07/11/2019

Event Type  Injury  

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.If information is provided in the future, a supplemental report will be issued.[(b)(4)].

Event 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: SUPERDIMENSION
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• 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: amy beeman ; 161 cheshire lane, suite 100; minneapolis, MN 55441 ; 7632104064
• MDR Report Key: 8931886
• MDR Text Key: 160128444
• Report Number: 3004962788-2019-00061
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 10884521199989
• UDI-Public: 10884521199989
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: AAS00161-20
• Device Catalogue Number: AAS00161-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/26/2019
• 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