AVEIR¿ RETRIEVAL SYSTEM CATHETER

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT PRESENTED TO IN IMPLANT PROCEDURE. DURING THE PROCEDURE, THE ATRIAL LEADLESS PACEMAKER EXHIBITED HIGH CAPTURE THRESHOLD AFTER FIXATION. THE PHYSICIAN THEN HAD DIFFICULTIES RELEASING THE DEVICE FROM THE DELIVERY CATHETER. ONCE THE DEVICE WAS RELEASED, IT DISLODGED AND MIGRATED TO THE INFERIOR VENA CAVA (IVC). A RETRIEVABLE CATHETER WAS UTILIZED TO RETRIEVE THE DEVICE. DURING EXTRACTION, THE DEVICE SEPARATED PREMATURELY FROM THE RETRIEVABLE CATHETER. ULTIMATELY, THE VASCULAR SURGEON WAS ABLE TO RETRIEVE THE DEVICE FROM THE PATIENT'S BODY. ADDITIONALLY, IT WAS NOTED THAT THE DEVICE'S HELIX WAS SPRUNG AT THE END OF THE RETRIEVAL PROCESS. ULTIMATELY, AN ATRIAL LEADLESS PACEMAKER WAS NOT IMPLANTED. THE PATIENT CONDITION WAS STABLE THROUGHOUT PROCEDURE.

Additional Manufacturer Narrative

THE REPORTED EVENT OF PREMATURE SEPARATION WAS NOT CONFIRMED. AS RECEIVED, A RETRIEVAL CATHETER WAS RETURNED IN ONE PIECE. VISUAL AND X-RAY INSPECTIONS OF THE CATHETER DID NOT FIND ANY ANOMALIES, EXCEPT FOR PROCEDURAL DAMAGE.