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

Model Number	CVI
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	01/08/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device evaluation will be provided in a follow-up report.
Event or Problem Description
A stemi procedure was performed on a (b)(6) year old male patient transferred from the emergency department.At the very beginning of the procedure, error messages appeared, "air column detected" and "turn off stopcock to the patient to purge." one entire bottle of contrast was purged.A new set up was drawn, and the same error messages occurred.After this, manual injections were done.The patient experienced chest pain, abnormal heart rhythm (vtach, vfib, asystole).Blood pressure <90 mmhg systolic, myocardial infarction, and cardiac biomarker elevation, trop 11.9.The outcome of the event was that the patient expired.
Additional Manufacturer Narrative
The acist angiographic contrast injection system, model cvi, serial number (b)(4), was returned to acist on january 12, 2018.The injection system was functionally tested and met the pre-established specifications.There was no evidence of device malfunction related to this event based on the data from the analysis of the injector.Based on the testing of the injector, there is no evidence of device malfunction related to this event.The consumable kits used during the case were discarded.The lot numbers are: a2000 syringe kit, lot# 27517t, bt2000 manifold kit, lot# 10117p and bt2000 manifold kit, lot# 54321237, and at-p65 hand controller kit, lot# 56260956.The device history was reviewed of the consumable lots used in the case, and no non-conformities were found.The cause of the event is inconclusive.This report is 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: 7234496
• Report Number: 2134243-2018-00005
• Device Sequence Number: 18859811
• Product Code: DXT
• UDI-Device Identifier: 10841716101233
• UDI-Public: (01)10841716101233(11)170825
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K010390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2018
• Supplement Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 02/01/2018
• Supplement Report FDA Received Date: 04/04/2018
• 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: AMIODARONE; ANGIOMAX; ASA; ATROPINE; CALCIUM CHLORIDE; DEXTROSE 50%; EPINEPHRINE; INSULIN; LIDOCAINE; METRONIC TEMPORARY PACER; MORPHINE; SODIUM BICARB; ZOFRAN; ZOLL
• Outcome Attributed to Adverse Event: Death
• Patient Age: 53 YR
• Patient Weight: 86