MAUDE brand profile
AMPLATZER STEERABLE DELIVERY SHEATH
MAUDE brand safety profile
Key facts
| Brand name | AMPLATZER STEERABLE DELIVERY SHEATH |
|---|
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems coded
- 1–9 Problems flagged by Orca1 signal analytics
- Air/Gas in Device, Non specific EKG/ECG Changes, Air Embolism, No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Improper or Incorrect Procedure or Method, Fluid/Blood Leak, Pericardial Effusion Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE brand safety profiles
Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1