MAUDE brand profile
AGILIS NXT STEERABLE INTRODUCER DUALREACH 61 CM SHEATH MEDIUM CURL 85F
MAUDE brand safety profile
Key facts
| Brand name | AGILIS NXT STEERABLE INTRODUCER DUALREACH 61 CM SHEATH MEDIUM CURL 85F |
|---|
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Gas/Air Leak, Fluid/Blood Leak, No Consequences Or Impact To Patient, Adverse Event Without Identified Device or Use Problem, Material Separation, Material Puncture/Hole, Detachment of Device or Device Component 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