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

Model Number	86410095
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	04/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bayer service visited the customer site and performed a system checkout.The injector was found to perform to specifications.The disposable information has been requested from the customer; however, no response has been received.An offer for additional applications training was made with no response at this time.
Event or Problem Description
The site reported the following: a patient was undergoing a tavr procedure and suffered an air injection while connected to the arterion injector system.The amount of air is unknown.The patient was reported to experience changes to their ekg, blood pressure, and oxygen saturation.No further details have been provided by the customer site following multiple attempts to obtain additional information.
Additional Manufacturer Narrative
Corrected data from initial report: the initial mdr 2520313-2020-00021 was submitted with udi number (b)(4) selected in section d4 in error.The correct udi number is (b)(4).

• Brand Name: MEDRAD ANGIOGRAPHIC/CT INJECTOR
• Common Device Name: ANGIOGRAPHIC/CT INJECTOR
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola, pa
• MDR Report Key: 10032471
• Report Number: 2520313-2020-00021
• Device Sequence Number: 2813044
• Product Code: DXT
• UDI-Device Identifier: 00616258009360
• UDI-Public: (01)00616258009360
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113133
• 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,Followup
• Report Date (Section B): 05/04/2020

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: 86410095
• Device Catalogue Number: ART 700 TABL
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 05/07/2020
• 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