ACIST
Report
- Report Number
- 2134243-2019-00013
- Event Type
- Death
- Date Received
- June 10, 2019
- Date of Event
- May 9, 2019
- Report Date
- May 10, 2019
- Manufacturer
- ACIST MEDICAL SYSTEMS, INC.
- Product Code
- DXT
- PMA / PMN Number
- K010390
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
ACIST HAS REQUESTED THAT THE ACIST ANGIOGPRAPHIC INJECTION SYSTEM MODEL CVI, SERIAL NUMBER: (B)(6) , AND THE ACIST CONSUMABLE KITS USED DURING THE EVENT BE SENT TO ACIST FOR INVESTIGATION. UPON COMPLETION OF THE INVESTIGATION, ACIST WILL SUBMIT A FOLLOW-UP REPORT TO FDA.
BASED ON INFORMATION RECEIVED FROM THE PHYSICIAN INVOLVED IN THIS EVENT, THE PHYSICIAN USED A NON-ACIST CATHETER BALLOON PUMP (I.E., MERIT MEDICAL COMPAK MAP 2026 BASIC). THE PHYSICIAN FILLED THE CATHETER BALLOON PUMP WITH CONTRAST MEDIA USING THE ACIST CONSUMABLE KIT THREE-WAY STOPCOCK. THE STOPCOCK, WHEN ATTACHED TO THE TUBING OF THE ACIST CVI CONSUMABLE KITS, IS LOCATED IN FLOW DIRECTION PAST THE AIR COLUMN DETECT (ACD) SENSOR OF THE CVI INJECTION SYSTEM, AND THEREFORE OUTSIDE THE CONTROL AREA OF AIR DETECTION BY THE ACD SENSOR. FEEDBACK FROM THE PHYSICIAN WAS THAT THERE WAS NO INDICATION OF A MALFUNCTION OF THE CVI INJECTION SYSTEM AND CONSUMABLE KITS. THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SERIAL NUMBER (B)(4), WAS RETURNED TO ACIST ON (B)(6) 2019. THE INJECTION SYSTEM WAS FUNCTIONALLY TESTED AND MET PRE-ESTABLISHED SPECIFICATIONS. THE ACIST CONSUMABLE KITS USED DURING THE EVENT WERE DISCARDED BY THE USER FACILITY AND THE LOT NUMBERS ARE UNKNOWN; THEREFORE, ACIST WAS UNABLE TO INVESTIGATE THESE ITEMS. 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. ONLY ACIST-PROVIDED CONSUMABLE KITS ARE DESIGNED, MANUFACTURED, AND TESTED FOR CONNECTION TO CATHETERS USED IN ANGIOGRAPHIC PROCEDURES. BASED ON TESTING AND EVALUATION OF THIS CVI INJECTION SYSTEM, THERE IS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THE REPORTED EVENT.
DURING A CORONARY ANGIOGRAPHY, AIR WAS INJECTED INTO A PATIENT. THE PHYSICIAN PREPARED A NON-ACIST INFLATOR DEVICE, RECONNECTED THE DEVICE AND TUBING TO THE CATHETER TO THE PATIENT, PERFORMED A TEST INJECTION OF CONTRAST MEDIA INTO THE PATIENT, AND OBSERVED THAT THERE WAS EVIDENCE OF AN AIR EMBOLISM IN THE PATIENT. THE PATIENT EXPERIENCED CHEST PAIN, ST-SEGMENT DEPRESSION, HYPOTENSION, BRADYCARDIA, ASYSTOLE, AND CARDIAC ARREST. THE PATIENT WAS INTUBATED AND VENTILATED. THE PATIENT WAS REPORTED TO BE STABLE AFTER THE EVENT. ON (B)(6) 2019, IT WAS REPORTED TO ACIST THAT THE PATIENT DIED THE NIGHT OF (B)(6) OR THE EARLY MORNING OF (B)(6) 2019.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 476907 | ACIST | INJECTOR AND SYRINGE, ANGIOGRAPHIC | DXT | ACIST MEDICAL SYSTEMS, INC. | CVI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 0 | 66 YR | Death | ABBOTT BMW HYDRO 3CM| ABBOTT XIENCE SIERRA| ASPEGIC| ATROPINE| BOSTON SCIENTIFIC GUIDE CORO STARTER| BOSTON SCIENTIFIC SYNERGY II| CELOCURINE| CORDIS INFINITI CATHETER| CORDIS JR| CORDIS XB| DIPRIVAN| HEPARIN| HYPNOMIDATE| INEXIUM| IOMERON 350| NIMBEX| RISORDAN| SALINE SOLUTION| TERUMO INTRODUCTEUR| TERUMO RYUJIN PLUS| VALIUM| VYGON TROUSSE VYSET | |
| 1 | 66 YR | Death | ABBOTT BMW HYDRO 3CM.| ABBOTT XIENCE SIERRA.| ASPEGIC.| ATROPINE.| BOSTON SCIENTIFIC GUIDE CORO STARTER.| BOSTON SCIENTIFIC SYNERGY II.| CELOCURINE.| CORDIS INFINITI CATHETER.| CORDIS JR.| CORDIS XB.| DIPRIVAN.| HEPARIN.| HYPNOMIDATE.| INEXIUM.| IOMERON 350.| MERIT MEDICAL COMPAK MAP 2026 BASIC.| NIMBEX.| RISORDAN.| SALINE SOLUTION.| TERUMO INTRODUCTEUR.| TERUMO RYUJIN PLUS.| VALIUM.| VYGON TROUSSE VYSET. |