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

Model Number	60726807
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	12/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer has declined an offer for a stellant injector checkout and additional applications training at this time.Bayer requested the return of the suspect disposables used during the incident; however, the customer has not responded.The customer was able to provide a lot number of the stellant ct disposable kit used during the incident.Bayer product analysis has requested retained samples for evaluation.Once received, additional investigation will be performed, and a follow up report will be submitted.
Event or Problem Description
The site reported the following: a (b)(6)-year-old male patient with an admitting diagnosis of chest pain underwent a cardiac ct scan with intravenous contrast enhancement while connected to a medrad® stellant ct injection system.On the final ct images, small air bubbles were observed in the patient's truncus pulmonale, right atrium and right ventricle.Although the patient was asymptomatic, he was admitted to the hospital for observation post procedure.The patient was later discharged and is reportedly doing well.
Additional Manufacturer Narrative
The customer has declined an offer for a stellant injector checkout and additional applications training at this time.Bayer requested the return of the suspect disposables used during the incident; however, the customer has not responded.The customer was able to provide lot numbers of the medrad® stellant multi-patient disposables used during the incident.Bayer product analysis evaluated and functionally tested retained samples of the subject lot numbers on (b)(6) 2021.The retained disposables were found to perform to specifications.This information does not constitute an admission that the device, the company or its employees caused or contributed to a reportable event.

• Brand Name: STELLANT DUAL CT INJECTOR
• Common Device Name: CT INJECTION SYSTEM
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 11237255
• Report Number: 2520313-2021-00004
• Device Sequence Number: 19645227
• Product Code: DXT
• UDI-Device Identifier: 00616258008943
• UDI-Public: (01)00616258008943
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K082905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2021

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: 60726807
• Device Catalogue Number: SCT W/CERTEGRA
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 02/10/2021
• 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: Hospitalization
• Patient Age: 48 YR