MAUDE Adverse Event Report: COEUR, INC. EMPOWER CTA CONNECTING TUBE; ACCESSORY, ANGIOGRAPHIC INJECTOR AND SYRINGE

Catalog Number	C465-2042/100114
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	07/11/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The coeur, inc.Instructions for use require the user to: "always visually inspect the fluid delivery system prior to use" and to "expel excess air from extension line(s) and all connections in the fluid delivery system prior to performing any procedures." the filing of this report was delayed due to the inability to access the fda's webtrader service and use of e-submitter.This has been resolved and the report is submitted following approval of the required test submission.
Event or Problem Description
Coeur, inc.Was notified by acist medical systems via e-mail from a regulatory compliance specialist on 21 july 2021 that an event occurred on (b)(6) 2021.The description of the event provided by acist stated that a patient was admitted into (b)(6) by an emergency physician on suspicion of cerebral infarction.Following a computed tomography (ct) scan with an empowercta injection system, which used both the empowerct fastload syringe, lot # 1866032008 and empowercta connecting tube, lot iaqvj-1903 as consumables), the patient went into cardiac arrest 20 minutes after the procedure.The user facility considered that air may have been injected into the patient, but this was not conclusive.It was reported the patient is deceased.
Additional Manufacturer Narrative
The ct scans were returned to couer's customer (acist medical systems) for evaluation by the acist medical advisory board (mab).Upon the mab's completed review, the following assessment was provided: "ct scans of the head were reviewed, and no air was visible.Based on the patient's status (acute stroke) and the absence of air identified on the patient's ct scans, there is insufficient evidence to indicate iv air administration occurred and thus no causal relationship established between the empowercta injection system and the reported patient death." the empower cta(r) connecting tube was included and used with the empower cta injection system.After review of the available information including the dhr of the cta(r) connecting tube and the acist mab review, couer concludes there is no causal relationship between the empower cta(r) connecting tube and the reported patient death.

• Brand Name: EMPOWER CTA CONNECTING TUBE
• Common Device Name: ACCESSORY, ANGIOGRAPHIC INJECTOR AND SYRINGE
• Manufacturer (Section D): COEUR, INC.; 209 creekside drive; washington NC 27889
• MDR Report Key: 12511741
• Report Number: 1038185-2021-00001
• Device Sequence Number: 3989653
• Product Code: DXT
• UDI-Device Identifier: M297620426
• UDI-Public: M297620426
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K150902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

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 Expiration Date: 03/28/2022
• Device Catalogue Number: C465-2042/100114
• Device Lot Number: IAQVJ-1903
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACIST MEDICAL SYSTEMS EMPOWERCT FASTLOAD SYRINGE.; ACIST MEDICAL SYSTEMS EMPOWERCTA INJECTION SYSTEM.; ACIST MEDICAL SYSTEMS EMPOWERCT FASTLOAD SYRINGE; ACIST MEDICAL SYSTEMS EMPOWERCTA INJECTION SYSTEM
• Outcome Attributed to Adverse Event: Death
• Patient Weight: 60