UNKNOWN_NEUROVASCULAR_PRODUCT
Received Jul 17, 2026 · Event occurred Jun 24, 2026
Report 3008881809-2026-00464 · MDR key 25864768
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
64 YR · Female
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE SUBJECT CATHETER WAS USED IN A PATIENT FOR RIGHT INTERNAL CAROTID ARTERY-CLINOID (C5) SEGMENT ANEURYSM FLOW DIVERTER IMPLANTATION PROCEDURE ON (B)(6) 2026. ON THE SAME DAY POST PROCEDURE PATIENT PRESENTED WITH ADVERSE EVENT AE#1 OOZING OF THE RIGHT GROIN ACCESS SITE THAT WAS TREATED WITH MANUAL PRESSURE, SANDBAGS AND SUTURE. COMPUTED TOMOGRAPHY ANGIOGRAPHY CTA WAS COMPLETED AND LIDO-EPI INJECTION WAS DONE. SPOT HGB DRAW COMPLETED AND LOW FROM BASELINE POTENTIALLY DUE TO OOZING. TREATED WITH PRBCS. AE STOP DATE - 25-JUN-2026. THIS EVENT WAS POSSIBLY RELATED TO SUBJECT SHEATH DEVICE AND DAPT. OUTCOME WAS RECOVERED/RESOLVED (NEXT DAY). NO FURTHER INFORMATION IS AVAILABLE.