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

Model Number	CVI SIEMENS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	09/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The acist angiographic contrast delivery system, model cvi siemens, serial number (b)(4), was returned to acist on (b)(6) 2017 for testing.The system was mechanically tested and diagnostic log files were reviewed.Additionally, the system device history record (dhr) was reviewed.Based on analysis of the injector system, there is no evidence of device malfunction related to this event.The consumable kits used during the event were discarded by the user facility and the lot numbers were not provided.Cine-angiograms were not provided to acist for evaluation.Two physicians at the user facility reviewed the case.These physicians indicated that the dissection appears to have been caused by a deep seated guiding catheter.Based on service testing performed on this system and dhr analysis, there is no evidence of device malfunction related to the reported event.The cause of the event is inconclusive.This report is considered closed.
Event or Problem Description
The user facility reported that during a case using the acist angiographic contrast delivery system, model cvi siemens, a dissection of the right coronary artery (rca) occurred.The exact date the case occurred was not reported and is unknown.The patient was undergoing a procedure for left heart catheterization (lhc) with possible percutaneous coronary intervention (pci) when the dissection occurred.The dissection was successfully repaired with a stent and the patient recovered.

• 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: 6963508
• Report Number: 2134243-2017-00011
• Device Sequence Number: 1324601
• Product Code: DXT
• UDI-Device Identifier: 10841716101349
• UDI-Public: (01)10841716101349(11)170407
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K991103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2017

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: Physician
• Device Model Number: CVI SIEMENS
• Device Catalogue Number: 014658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/19/2017
• 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: Life Threatening; Required Intervention