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 Codes	Air Embolism (1697); Embolism (1829)
Date of Event	03/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bayer service performed a check of the injector and found it to perform to specification.The disposables involved in the procedure were discarded by the site and the lot number was not known.The site was offered clinical applications assistance and declined the offer.This information does not constitute an admission that the device, the company or its employees caused or contributed to a reportable event.
Event or Problem Description
The site reported the following: a (b)(6) year old female patient was undergoing a ct of the chest for a suspected pulmonary embolus and was injected with contrast media using a stellant injector.The patient had a positive d-dimer test and had experienced chest pain prior to arriving in ct.The radiologist interpreting the study visualized a large amount of air in the right subclavian vein, svc, right atrium and right ventricle.The patient experienced no symptoms; however, she was proactively placed in the trendelenburg position.The following day, a ct of the chest without contrast was performed.The radiologist reviewed the images and found complete resolution of the previously noted air.The patient was discharged to home in good condition.

• Brand Name: STELLANT DUAL CT INJECTOR
• Common Device Name: CT INJECTION SYSTEM
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; one bayer drive; indianola PA 15051
• MDR Report Key: 8524235
• Report Number: 2520313-2019-00022
• Device Sequence Number: 1884279
• Product Code: DXT
• UDI-Device Identifier: 00616258008943
• UDI-Public: (01)00616258008943
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 04/17/2019

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: 60726807
• Device Catalogue Number: SCT D
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/17/2019
• 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: Hospitalization
• Patient Age: 53 YR