inforMED
MalfunctionMMX

AVEIR¿ RETRIEVAL SYSTEM CATHETER

Received Sep 2, 2025 · Event occurred Aug 14, 2025

Report 2017865-2025-99162 · MDR key 22948708

Device

Generic name

Device, Percutaneous Retrieval

Model number

LSCR111

Lot number

10400078

Product problems

  • Premature Separation
  • Premature Separation

Patient

74 YR · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC ON (B)(6) 2025 FOR INITIAL IMPLANT PROCEDURE. DURING PROCEDURE, IT WAS FOUND THAT THE RIGHT VENTRICULAR (RV) LEADLESS PACEMAKER (LP) WAS DISLODGED DURING TETHER MODE. WHEN THE RVLP WAS BEING RECOVERED WHILE IT WAS STILL CONNECTED TO THE DELIVERY CATHETER, THE RVLP SEPARATED PREMATURELY FROM THE CATHETER, CAUSING EMBOLISM, AND THE RVLP WAS SITTING FREELY IN THE RIGHT VENTRICLE. WHEN THE RVLP WAS BEING RETRIEVED BY THE RETRIEVAL CATHETER, THE CATHETER WAS LOOSED UP TO RE-ADJUST THE DEVICE FOR RETRIEVAL, BUT THE RVLP SLIPPED AND MIGRATED INTO THE RIGHT ATRIUM. EVENTUALLY, THE RVLP WAS RETRIEVED, NOT IMPLANTED, AND AN ALTERNATE NEAR AT HAND WAS IMPLANTED SUCCESSFULLY INSTEAD. THE FIRST DELIVERY CATHETER USED WAS THEN EXAMINED, WHERE IT WAS FOUND THAT ACTIVATION FAILURE WAS EXHIBITED. PATIENT CONDITION WAS STABLE.