MAUDE Adverse Event Report: BAYER MEDICAL CARE INC MEDRAD ANGIOGRAPHIC/CT INJECTOR

Model Number	60726793
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Air Embolism (1697); Stroke/CVA (1770); Low Oxygen Saturation (2477)
Date of Event	02/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Bayer medical care inc.Was informed that 65-year-old male had experienced left-sided weakness and a drop in oxygen saturation levels during a left heart catheterization while connected to a medrad® mark 7 arterion injection system (sn (b)(6)).Medical staff suspected an alleged air injection occurred while the injector was connected to the patient; however, this was not confirmed on the fluoroscopic images from the procedure.Following the development of the reported symptoms, a stroke code was called, the patient was given medication, a temporary pacemaker, and was taken to the radiology department where a ct of the head was performed, and air was visualized on the displayed images.The amount of air was not quantified.The patient is in the icu and is reported as being stable.
Additional Manufacturer Narrative
A system service check of the medrad® mark 7 arterion injection system (sn (b)(6)) was performed on (b)(6) 2025, which confirmed that the injector was operating within bayer specifications.The disposables that were in use during the procedure were discarded by the site; therefore, they are not available for evaluation.The customer was unable to provide the lot number of the disposables used during the procedure; therefore, testing of retained samples was not possible.The offer of additional clinical applications training was accepted by the customer and is being provided by the clinical performance center.The medrad® mark 7 arterion injection system operation manual cautions the user as follows: purge all air from syringe and disposables before connecting or injecting to patient.Before arming, the system prompts the operator to confirm that air has been purged from the syringe and disposable set.Once in the armed state, the system will not prompt the operator to check for air unless the operator performs an action that may introduce air.It is the operator's responsibility to successfully purge all air from the system.The purged air confirmation icon displays on the display control unit after the operator confirms air is expelled from syringe and disposable set.This information does not constitute an admission that the device, the company, or its employees caused or contributed to a reportable event.

• Brand Name: MEDRAD ANGIOGRAPHIC/CT INJECTOR
• Common Device Name: ANGIOGRAPHIC/CT INJECTOR
• Manufacturer (Section D): BAYER MEDICAL CARE INC; 1 bayer drive; indianola PA 15051
• Manufacturer (Section G): BAYER MEDICAL CARE INC; 1 bayer drive; indianola PA 15051
• Manufacturer Contact: jason johnson ; 1 bayer drive; indianola, PA 15051 ; 4124063016
• MDR Report Key: 21584442
• Report Number: 2520313-2025-00009
• Device Sequence Number: 8757723
• Product Code: DXT
• UDI-Device Identifier: 00616258009360
• UDI-Public: (01)00616258009360(11)170815
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K113133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/12/2025

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: 60726793
• Device Catalogue Number: ART 700 TABL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male