AXS INFINITY LS PLUS .091IN ID X 90CM-CE
Received Jun 22, 2026 · Event occurred Jun 10, 2026
Report 3008853977-2026-00013 · MDR key 25577940
Device
Generic name
Catheter, Percutaneous
Manufacturer
Stryker Neurovascular-califCatalog number
INC-11987-90
Lot number
26803-01
Product problems
- Fracture
Patient
NA · Unknown
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE SUBJECT CATHETER ENCOUNTERED RESISTANCE WHILE REMOVING FROM ITS SHEATH. THE SUBJECT CATHETER BROKE INSIDE THE PATIENT AND THE METAL COILS INTEGRATED WITH THE DISTAL WALL OF THE CATHETER BECAME STRETCHED. THE FRACTURED DISTAL PORTION OF THE SUBJECT CATHETER WAS RETRIEVED USING A SNARE. THIS MANEUVER CAUSED LOCAL BLEEDING AT THE PUNCTURE SITE, WHICH WAS CONTROLLED BY MANUAL COMPRESSION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.