MAUDE Adverse Event Report: LIEBEL-FLARSHEIM INJ. OPTIV DH,SI W/OEM

Model Number	844005
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	02/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Preliminary results: air injections are generally not related to the injector, but are generally user related causes.The optivantage is not equipped with air detectors; however, the ifu includes instructions for the proper purging of air from the system prior to injection, as well as precautions and steps to prevent air injections.Additionally, the optivantage sends a prompt to the operator requiring the operator to ensure all air is purged from the system and associated consumables prior to the injection.The operator must press the screen acknowledging this has been completed prior to the device enabling the injection.For these reasons, air injections are generally user related.
Event or Problem Description
This case was reported by a facility in france on (b)(6) 2025.Customer states that on (b)(6)2025 that after the injection of optiray 350 using the optivantage injector, air was injected.Treatment and management of the patient following this injection of air bubbles: extended 15l 02 sent to the (b)(6).

• Brand Name: INJ. OPTIV DH,SI W/OEM
• Common Device Name: INJ. OPTIV DH,SI W/OEM
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e. galbraith rd; cincinnati OH 45237
• Manufacturer Contact: jacob miller ; 2111 e. galbraith rd; cincinnati, OH 45237 ; 5139485765
• MDR Report Key: 21566665
• Report Number: 1518293-2025-00004
• Device Sequence Number: 21147790
• Product Code: IZQ
• UDI-Device Identifier: 10746190002710
• UDI-Public: 0110746190002710
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2025

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: 844005
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2021
• 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: Other
• Patient Age: 48 YR
• Patient Sex: Unknown