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

Model Number SD300LG

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

Patient Problem Air Embolism (1697)

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Literature review per fogelfeld, k., et al.(2018)."cerebral artery gas embolism following navigational bronchoscopy." journal of intensive care medicine, january 22,2018.A (b)(6) male patient developed a cerebral artery gas embolism (cage).One hour after an electromagnetic navigational bronchoscopy (enb) procedure.The patient had increasing confusion with left arm myoclonus and right upper extremity twitching, a left gaze preference, and possibly left facial droop.He was lethargic, but able to move all extremities, and responded to questions with his name, but had no other verbal output.A ct of the head revealed 2 low-density foci in the right hemisphere suggestive of air embolism.He was given labetalol, lorazepam with cessation of seizure activity, however became bradycardic without a palpable pulse.Advanced cardiac life support was started, and his pulse returned.Hemodynamics were normal and he was intubated and placed on oxygen.A brain magnetic resonance imaging (mri) revealed right cerebral hemisphere gyriform cortical edema.There was no evidence of air emboli sm on the mri.He was emergently transferred to a facility with a hyperbaric oxygen chamber and underwent 2 treatments.He was extubated 3 days after the procedure.A 6 month follow-up eeg was totally normal.

Manufacturer Narrative

Please see additional information in sections.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EDGE
• 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: 7602407
• MDR Text Key: 111098848
• Report Number: 3004962788-2018-00029
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 10884521199514
• UDI-Public: 10884521199514
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SD300LG
• Device Catalogue Number: SD300LG
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention