MAUDE Adverse Event Report: BAYER MEDICAL CARE, INC. AVANTA FLUID MANAGEMENT SYSTEM; ANGIOGRAPHIC INJECTOR

Model Number	60726742
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	01/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to a bayer representative that an alleged air injection occurred on a (b)(6) male patient while utilizing the avanta fluid management system ((b)(4)) to perform a coronary angiography procedure.During the first injection, with the catheter located in the left coronary artery, 5 ml of air was observed on the fluoroscopic images.The patient suffered a transient cardiac arrest but was reported to later recover.
Additional Manufacturer Narrative
A system service check of the avanta fluid management system was completed by bayer service and found that the injection system performed to specifications.The multi-patient sterile disposable set (mpat) and the single-patient sterile disposable set (spat) that were in use during the procedure were discarded by the site.However, the site was able to provide the lot number of the mpat syringe only that was in use.A retained sample has been requested and will be examined once received.The customer has been offered additional applications training and has accepted.A site visit is being scheduled.A follow up report will be submitted once the investigation is completed.
Additional Manufacturer Narrative
A system service check of the avanta fluid management system was completed by bayer service and found that the injection system performed to specifications.The multi-patient sterile disposable set (mpat) and the single-patient sterile disposable set (spat) that were in use during the procedure were discarded by the site.However, the site was able to provide the lot number of the mpat syringe only that was in use.A retained sample has been received and examined and found to perform to specifications.The customer has been offered additional applications training and has accepted.A site visit is being scheduled.This information does not constitute an admission that the device, the company, or its employees caused or contributed to a reportable event.

• Brand Name: AVANTA FLUID MANAGEMENT SYSTEM
• Common Device Name: ANGIOGRAPHIC 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: susan sherwin ; 1 bayer drive; indianola, PA 15051 ; 7249408678
• MDR Report Key: 13536776
• Report Number: 2520313-2022-00008
• Device Sequence Number: 12021493
• Product Code: DXT
• UDI-Device Identifier: 00616258008578
• UDI-Public: (01)00616258008578
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K050456
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

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: 60726742
• Device Catalogue Number: AVA 500 PEDL
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MULTI-PATIENT STERILE DISPOSABLE SET (MPAT).; SINGLE-PATIENT STERILE DISPOSABLE SET (SPAT).
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 45 YR
• Patient Sex: Male