AVEIR¿ RETRIEVAL SYSTEM CATHETER

Additional Manufacturer Narrative

THE REPORTED EVENTS OF DIFFICULTY ATTACHING THE RETRIEVAL CATHETER TO THE LEADLESS PACEMAKER AND PREMATURE SEPARATION WERE CONFIRMED. AS RECEIVED, A CATHETER WAS RETURNED IN ONE PIECE. VISUAL AND X-RAY EXAMINATIONS OF THE CATHETER FOUND THAT THE CINCHER TUBE WAS DAMAGED CONSISTENT WITH PROCEDURAL DAMAGE IN TWO LOCATIONS AT THE DISTAL REGION OF THE CATHETER. THE CAUSE OF THE REPORTED EVENTS WAS ISOLATED TO PROCEDURAL DAMAGE.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE INITIAL IMPLANT PROCEDURE, THE RIGHT VENTRICLE (RV) LEADLESS PACEMAKER (LP) WAS DIFFICULT TO DOCK TO THE DELIVERY CATHETER. AFTER FIXATION AND RELEASE, THE LP BECAME LODGED HORIZONTALLY IN THE TRICUSPID VALVE. MULTIPLE ATTEMPTS TO RETRIEVE THE LP WERE MADE DUE TO DIFFICULTY ATTACHING IT TO THE RETRIEVAL CATHETER. WHEN RETRIEVING THE RV LP WITH THE RETRIEVAL CATHETER, THE RV LP PREMATURELY SEPARATED FROM THE RETRIEVAL CATHETER AND DISLODGED TO THE RIGHT ATRIUM. THE RV LP WAS ABLE TO BE RETRIEVED AND REPLACED TO RESOLVE THE EVENT. THE PROLONGATION OF THE PROCEDURE WAS CLINICALLY SIGNIFICANT. THE PATIENT WAS IN STABLE CONDITION.