FDA Adverse Event
Other
Summary report: N
ACIST
MDR report key: 485131
·
Received September 18, 2003
Report
- Report Number
- 2134243-2003-00001
- Event Type
- Other
- Date Received
- September 18, 2003
- Date of Event
- October 5, 2000
- Report Date
- September 18, 2003
- Manufacturer
- ACIST MEDICAL SYSTEMS, INC.
- Product Code
- DXT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DURING THE SECOND AND THIRD INJECTION OF THE LEFT CORONARY ARTERY, AIR WAS INJECTED INTO THE PATIENT. IT WAS REPORTED THAT THE PATIENT ENCOUNTERED ARRHYTHMIAS AND ST ELEVATIONS AS A RESULT. THESE WERE TRANSIENT AND SUBSIDED WITHIN A COUPLE OF MINUTES. THE ATTENDING PHYSICIAN AND THE SCRUB TECH STATED THAT THE AIR EMBOLISM WAS DUE TO THE SYSTEM, AS THEY DID NOT EXCHANGE CATHETERS, ASPIRATE, FLUSH, OR RE-POSITION THE CATHETER FROM THE FIRST LCA INJECTION. SITE WENT ON TO USE THE SYSTEM SUCCESSFULLY FOR THE RIGHT CORONARY ARTERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACIST | ANGIOGRAPHIC INJECTION SYSTEM | DXT | ACIST MEDICAL SYSTEMS, INC. | CL100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |