MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS, INC. ACIST; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Model Number	CVI
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	08/12/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient age and birthdate are unknown.Estimated age and birthdate are entered into these fields.Patient weight is not known.The acist angiographic injection system, model cvi, serial number (b)(4), was requested to be returned for evaluation on (b)(6) 2020.The consumable kits used during the procedure were discarded and the lot numbers are not known.Patient information has not yet been received, and copies of the cine-angiograms have been requested to be returned to acist for evaluation.Upon completion of the investigation, a follow-up report will be submitted to fda.
Event or Problem Description
During a catheterization procedure, air was injected into a patient.The user reported that the transducer was not providing a pressure waveform; the user replaced the transducer.The user repeated the setup of the consumable kits with the acist angiographic injection system, model cvi.At the start of the procedure, upon the first injection of contrast, the user observed a small amount of air.Post the air injection, the patient expired.
Additional Manufacturer Narrative
H2: the acist angiographic injection system, model cvi, serial number (b)(6), was returned to acist on august 19, 2020.The injector system was functionally tested and met the pre-established specifications.The consumables used during the event were discarded and the lot numbers are not known.Acist has not yet received a copy of the cine-angiograms of the event.If the cine-angiograms are received, they will be reviewed by acist's medical advisor.Upon completion of these reviews, a follow-up report will be submitted to fda.The instructions for use have been reviewed and no inadequacies were identified regarding warnings, contraindications, and the directions/conditions for the use of the device.There is no evidence of device malfunction related to this event and no inadequacies related to the device labeling/instructions for use.
Additional Manufacturer Narrative
H2: despite several requests by acist for additional information and a copy of the cine-angiograms, the user facility elected not to provide the additional information or a copy of the cine-angiograms.Should this information become available at a future date, acist will submit a follow-up report to fda.This report is considered closed.

• Brand Name: ACIST
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): ACIST MEDICAL SYSTEMS, INC.; 7905 fuller road; eden prairie MN 55344
• MDR Report Key: 10517921
• Report Number: 2134243-2020-00010
• Device Sequence Number: 19638888
• Product Code: DXT
• UDI-Device Identifier: 40841716101876
• UDI-Public: (01)40841716101876(11)190927
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K010390
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2020

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: CVI
• Device Catalogue Number: 014657
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 08/12/2020; 08/12/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 09/11/2020; 11/18/2020
• 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: Death
• Patient Age: 50 YR