MAUDE Adverse Event Report: BAYER MEDICAL CARE, INC. STELLANT DUAL CT INJECTOR; CT INJECTION SYSTEM

Model Number	85937286
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	07/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A system service check of the stellant ct injector, serial number (b)(4), was completed on (b)(6) 2020 which confirmed that the injector was operating within bayer specifications.The stellant disposable set that was in use during the procedure was discarded by the site; and lot numbers were unable to be provided; therefore, testing of retained samples is unable to be performed.Additional applications training was offered; however, the site declined.
Event or Problem Description
A bayer representative received the following information: a (b)(6) year old male patient with history of carotid stenosis underwent a cta of the carotid arteries while connected to a stellant ct injector system.During the injection the patient suffered an extravasation of contrast, exact amount unknown.Post procedure, the patient was treated with a cold compress, dermatology was consulted, and corticosteroids were administered.No further medical intervention was reported.

• Brand Name: STELLANT DUAL CT INJECTOR
• Common Device Name: CT INJECTION SYSTEM
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola, pa
• MDR Report Key: 10343883
• Report Number: 2520313-2020-00029
• Device Sequence Number: 3178396
• Product Code: DXT
• UDI-Device Identifier: 00616258020860
• UDI-Public: (01)00616258020860
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K082905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2020

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: 85937286
• Device Catalogue Number: SCT W/CERTEGRA
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 07/30/2020
• 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: Required Intervention
• Patient Age: 67 YR