MAUDE manufacturer profile
BIOSENSE WEBSTER INC · QZI
MAUDE profile for Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
Key facts
| Manufacturer | BIOSENSE WEBSTER INC |
|---|---|
| Manufacturer group | BIOSENSE WEBSTER INC (JUAREZ) |
| Product code | QZI |
| Product code name | Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Patient Device Interaction Problem, Stroke/CVA, No Clinical Signs, Symptoms or Conditions, Cardiac Tamponade, Mechanical Jam, Coagulation in Device or Device Ingredient, Transient Ischemic Attack, Device Contamination with Body Fluid Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1