inforMED
InjuryDQY

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

Catalog 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.