AVEIR¿ RETRIEVAL SYSTEM CATHETER
Received May 22, 2024 · Event occurred Nov 15, 2023
Report 2017865-2024-42194 · MDR key 19378316
Device
Generic name
Device, Percutaneous Retrieval
Manufacturer
St. Jude Medical, Inc.(crm-sylmar)Model number
LSCR111Lot number
9016137
Product problems
- Connection Problem
- Connection Problem
Patient
NA · Unknown
- Low Blood Pressure/ Hypotension
- Cardiac Perforation
- Pericardial Effusion
- Low Blood Pressure/ Hypotension
- Cardiac Perforation
- Pericardial Effusion
Narrative
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.
Description of Event or Problem
IT WAS REPORTED THE PATIENT PRESENTED FOR AN ATRIOVENTRICULAR NODE ABLATION. FOLLOWING THE PROCEDURE, THE LONGEVITY ESTIMATE ON THE LEADLESS PACEMAKER (LP) DECREASED AND THE CAPTURE THRESHOLD INCREASED. THE PATIENT PRESENTED FOR EXPLANT PROCEDURE ON (B)(6)2024. DURING THE PROCEDURE, THE REPLACEMENT LP WAS IMPLANTED AND EXPLANT OF THE OLD LP WAS ATTEMPTED. THE RETRIEVAL CATHETER FAILED TO CONNECT TO THE DOCKING BUTTON ON THE OLD LP. THE OLD LP WAS DEACTIVATED. AT THE END OF THE PROCEDURE, AN EFFUSION WAS DISCOVERED WHEN THE PATIENT'S BLOOD PRESSURE RAPIDLY DROPPED. PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION POST-PROCEDURE.