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

Model Number	CVI SIEMENS
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/16/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The acist angiographic injection system, model cvi siemens, serial number (b)(4) was requested to be returned for evaluation on (b)(6) 2020, and has not yet been received.The consumable kits used during the procedure were discarded by the user facility.The lot numbers of the consumable kits used during the event were provided.Review of the manufacturing records will be completed.Copies of the cine-angiograms have been requested to be returned to acist for the acist medical advisory board's evaluation.The acist clinical specialist completed an onsite follow-up visit with this user facility.Upon completion of the investigation, a follow-up report will be submitted to fda.
Event or Problem Description
During a left ventricle and coronary catheterization (lvc) for elevated stress, a coronary dissection of the left main artery occurred after the second injection of the left coronary system.The patient's condition during and after the event was stable.The patient experienced chest pain for a period subsequent to the event.The patient was transferred to another hospital, and it was reported by the acist clinical specialist that the patient is deceased.
Additional Manufacturer Narrative
H3: the acist angiographic injection system, model cvi siemens, serial number: (b)(6), was returned to acist on december 21, 2020.The injector system was functionally tested and met the pre-established specifications.Review of the device history records for the cvi consumable kit lots used during the event; acist single-use manifold kit, model: bt2000, lot: 24020d, and acist angiotouch hand controller kit, model: at-p65, 21620t, will be submitted in a follow-up report.The cine-angiograms were not returned for evaluation therefore could not be reviewed by the acist medical advisory board member.
Additional Manufacturer Narrative
H2: the consumable kits were discarded by the user facility; the lots numbers of the consumable kits were provided.A review of the device history records was completed on february 05, 2021, for the following cvi consumable kit lots used during the event: acist single-use manifold kit, model: bt2000, lot: 24020d, and acist angiotouch hand controller kit, model: at-p65, 21620t.This review confirmed that there were no manufacturing quality issues for these lots related to the reported event.Based on testing and evaluation of this cvi injection system, there is no evidence of device malfunction related to the reported event.There were no cine-angiograms available for the acist medical advisory board member to review.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: 10997296
• Report Number: 2134243-2020-00012
• Device Sequence Number: 10938662
• Product Code: DXT
• UDI-Device Identifier: 10841716101905
• UDI-Public: (01)10841716101905(11)191217
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2020

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 SIEMENS
• Device Catalogue Number: 014657
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 11/16/2020; 11/16/2020
• Initial Report FDA Received Date: 12/13/2020
• Supplement Report FDA Received Date: 02/02/2021; 02/12/2021
• 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: FENTANYL.; HEPARIN.; MEDTRONIC 3J GUIDEWIRE LOT GFES2401.; TERUMO GLIDESHEATH.; TERUMO GUIDE CATHETER.; VERAPAMIL.; VERSED.; VISIPAQUE.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 78 YR
• Patient Weight: 79