AVEIR¿ RETRIEVAL SYSTEM CATHETER
Received Oct 9, 2025 · Event occurred Sep 24, 2025
Report 2017865-2025-1002311 · MDR key 23256605
Device
Product problems
- Break
- Connection Problem
- Break
- Connection Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING THE INITIAL IMPLANT PROCEDURE, THE PHYSICIAN EXPRESSED A USER CONCERN OF DISSATISFACTION WITH THE DEFLECTION CAPABILITIES OF THE DELIVERY CATHETER. THE RIGHT VENTRICLE (RV) LEADLESS PACEMAKER (LP) WAS IMPLANTED, HOWEVER, LOSS OF CAPTURE WAS NOTED. THE PHYSICIAN ATTEMPTED TO EXPLANT THE RV LP, HOWEVER, THE LP WAS UNABLE TO CONNECT WITH THE RETRIEVAL CATHETER. THE LP WAS ABLE TO BE EXPLANTED WITH ANOTHER PROCEDURAL TOOL AND THE RV LP WAS REPLACED. THE PHYSICIAN CONSIDERED THE PROLONGATION OF THE SURGERY TO BE CLINICALLY SIGNIFICANT. THE PATIENT WAS IN STABLE CONDITION.
Additional Manufacturer Narrative
A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND ALL REQUIRED MANUFACTURING PROCESSES AND INSPECTIONS STEPS WERE CONFIRMED TO BE COMPLETED PER THE REQUIREMENTS. THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING ABBOTT MANUFACTURING FACILITIES.