Device product
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016260 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.
Z-1286-2021
Product summary
- Event
- Event 87440
- Status
- Completed
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1286-2021
Official wording
Reason: There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism
Code information: All Lots
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism