FDA Adverse Event
Summary report: N
NAMIC STANDARD PERIPHERAL VASCULAR ANGIOGRAPHIC KIT
MDR report key: 4934791
·
Received July 7, 2015
Report
- Report Number
- 4934791
- Date Received
- July 7, 2015
- Date of Event
- May 7, 2015
- Report Date
- July 7, 2015
- Manufacturer
- NAVILYST MEDICAL, INC., AN ANGIODYNAMICS COMPANY
- Product Code
- DTZ
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
A PATIENT WAS IN THE CATHETERIZATION LAB FOR A HEART CATHETERIZATION. AN AIR EMBOLISM OCCURRED. PROBABLE CAUSE: DEFECTIVE MANIFOLD SYSTEM (NAMIC KIT, LOT # 60041082, ITEM SEQUESTURED). PATIENT CONDITIONS: HEART RATE BRADYCARDIA TO 43, BLOOD PRESSURE (BP) 91/61, CHEST PAIN, PALE. THE PATIENT WAS TREATED WITH ATROPINE, NEOSYNEPHRINE, EPINEPHRINE, AND ASPIRATING AIR FROM THE RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS STABLE AT END OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 440182 | NAMIC STANDARD PERIPHERAL VASCULAR ANGIOGRAPHIC KIT | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | NAVILYST MEDICAL, INC., AN ANGIODYNAMICS COMPANY | * | 60041082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |