FDA Adverse Event Death Summary report: N

ACIST CVI® CONTRAST DELIVERY SYSTEM

MDR report key: 17594915 · Received August 22, 2023

Report

Report Number
17594915
Event Type
Death
Date Received
August 22, 2023
Date of Event
August 3, 2023
Report Date
August 20, 2023
Manufacturer
ACIST MEDICAL SYSTEMS, INC.
Product Code
DXT
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
IA
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PATIENT WAS SCHEDULED TO UNDERGO A CARDIAC CATH TO TREAT POSSIBLE CORONARY ARTERY DISEASE. AFTER ALL APPROPRIATE PROCEDURES WERE DONE TO PREPARE THE CONTRAST INJECTION DEVICE, THE PROVIDER INJECTED DYE INTO THE CORONARY ARTERIES VIA A RIGHT RADIAL CATHETER. THE TEAM MEMBER MONITORING THE PROCEDURE, WHO WAS RECORDING THE FLUOROSCOPY RECORDING NOTED WHAT APPEARED TO BE AIR IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND CIRCUMFLEX ARTERIES WITH WHAT APPEARED TO BE CARDIAC STANDSTILL. HE IMMEDIATELY ALERTED THE PROVIDER AND OTHER TEAM MEMBERS, AND EMERGENCY MEASURES WERE INITIATED. THE PATIENT WAS INTUBATED, AND CARDIAC MEDICATIONS WERE GIVEN. THE PROVIDER PLACED A SECOND LINE AND PROCEEDED TO PERFORM A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) IN THE 100% OCCLUDED ARTERIES. THIS WAS SUCCESSFUL WITH REDUCING THE BLOCKAGE TO 0%. AN INTRA-AORTIC BALLOON PUMP (IAPB) WAS ALSO PLACED TO ASSIST WITH CARDIAC FUNCTION. HOWEVER, THEY WERE NOT ABLE TO GET CARDIAC FUNCTION TO RETURN ON ITS OWN. DESPITE ADVANCED CARDIAC LIFE SUPPORT (ACLS) MEASURES AND WORKING ON THE PATIENT FOR APPROXIMATELY 90 MINUTES, HE WAS DECLARED DEAD. INITIALLY, THE PROVIDER FELT THIS EVENT OCCURRED DUE TO A POSSIBLE "CLOT SHOWER" VS AIR EMBOLI. INVESTIGATION FROM OUR SIDE DID NOT IDENTIFY ISSUES WITH THE ACIST CVI INJECTOR DEVICE AS OUR BIOMED TECHNICIAN EXAMINED THE DEVICE. HOWEVER, WE COULD NOT RULE OUT ISSUES WITH THE OTHER PARTS OF THE SYSTEM INCLUDING THE TUBING, SYRINGE, OR MANIFOLD. THE DEVISE LOT NUMBERS ARE ASSUMED AS THESE ITEMS WERE IN THE SUPPLY AREA WHERE THIS EVENT OCCURRED. MANUFACTURER RESPONSE FOR CONTRAST INJECTION SYSTEM, ACIST CVI (PER SITE REPORTER). WAITING FOR THEIR REPORT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
53464 ACIST CVI® CONTRAST DELIVERY SYSTEM INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC.

Patients

Seq Age Sex Outcome Treatment
1 26280 DA Male Death