EXCIPIO SV
Received Jul 14, 2026 · Event occurred Jul 29, 2023
Report 3011471056-2026-00051 · MDR key 25819331
Device
Generic name
Embolectomy Catheter
Manufacturer
Contego Medical, Inc.Model number
EXC-0940-165Catalog number
EXC-0940-165
Lot number
EXF033123-01
Product problems
- Detachment of Device or Device Component
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DR. USED AN EXCIPIO SV ON FOR A PATIENT WITH ACUTE THROMBOSIS OF A RIGHT FEM POP BYPASS GRAFT. FROM THE LEFT FEMORAL ARTERY THE DEVICE USED PLACED THROUGH A PENUMBRA INDIGO SYSTEM LIGHTNING 7 (LITNG7XTORQ130) AND USED IN THE RIGHT FEM POP BYPASS GRAFT TO CLEAR OUT THROMBUS. WHILE BEING USED THE EXPANDABLE BASKET BECAME SEPARATED FORM THE DEVICE, FORTUNATELY THE SEPARATED SEGMENT WAS WITHIN THE LIGHTNING CATHETER AND REMOVED WITHOUT ISSUE. THE CASE CONTINUED WITHOUT ANY FURTHER ISSUE.
Additional Manufacturer Narrative
THIS MDR IS A REMEDIAL SUBMISSION. FOLLOWING A RETROSPECTIVE REASSESSMENT, THE MANUFACTURER DETERMINED THAT THE EVENT MEETS THE REPORTABILITY CRITERIA UNDER 21 CFR PART 803.