MAUDE Adverse Event Report: BAYER MEDICAL CARE ARTERION; CARDIOVASCULAR PROCEDURE KIT

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

Patient Problem Air Embolism (1697)

Event Date 03/03/2022

Event Type  Injury  

Event Description

Cath lab procedure.Questionable air embolism during procedure.Reported to director by physician post case.Patient was taken to ct from cath lab.

• Brand Name: ARTERION
• Type of Device: CARDIOVASCULAR PROCEDURE KIT
• Manufacturer (Section D): BAYER MEDICAL CARE; 1 bayer drive; indianola PA 15051
• MDR Report Key: 15665641
• MDR Text Key: 302351836
• Report Number: 15665641
• Device Sequence Number: 1
• Product Code: OEZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 24090 DA
• Patient Sex: Male