MAUDE manufacturer profile
MEDTRONIC CRYOCATH LP · OAE
MAUDE profile for Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Key facts
| Manufacturer | MEDTRONIC CRYOCATH LP |
|---|---|
| Manufacturer group | MEDTRONIC CRYOCATH LP |
| Product code | OAE |
| Product code name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, No Known Impact Or Consequence To Patient, Material Twisted/Bent, Nerve Damage, No Clinical Signs, Symptoms or Conditions, Material Integrity Problem, Pericardial Effusion, Cardiac Tamponade 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