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
Manufacturer
St. Jude Medical, Inc.(crm-sylmar)Model number
LSCR111Lot 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.