AVEIR¿ RETRIEVAL SYSTEM CATHETER
Received Nov 13, 2025 · Event occurred Oct 28, 2025
Report 2017865-2025-1004971 · MDR key 23548008
Device
Generic name
Device, Percutaneous Retrieval
Manufacturer
St. Jude Medical, Inc.(crm-sylmar)Model number
LSCR111Lot number
10518009
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- Embolism/Embolus
- Embolism/Embolus
Narrative
Additional Manufacturer Narrative
THE REPORTED EVENT OF ¿THE INTEGRATED TRI-LOOP SNARE SEPARATED FROM THE RETRIEVAL CATHETER¿ WAS CONFIRMED. AS RECEIVED, A COMPLETE CATHETER WAS RETURNED WITHOUT THE TRI-LOOP SNARES. VISUAL AND X-RAY INSPECTION FOUND THE TRI-LOOP SNARE DETACHED FROM THE CATHETER¿S DISTAL TIP. THE CAUSE OF THE REPORTED EVENT WAS ISOLATED TO THE DAMAGED CATHETER CONSISTENT WITH PROCEDURAL DAMAGE. ABBOTT IS CONTINUING TO MONITOR THIS ISSUE.
Description of Event or Problem
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-1004968. IT WAS REPORTED THAT A PATIENT PRESENTED FOR A RIGHT ATRIAL LEADLESS PACEMAKER (LP) EXPLANT PROCEDURE. PATIENT HAD COMPLAINED ABOUT CHEST PAIN POSSIBLY RELATED TO PREMATURE VENTRICULAR CONTRACTIONS OR HIGH CAPTURE THRESHOLDS. DURING THE EXPLANT, THE TRI-LOOP SNARE DETACHED FROM THE RETRIEVAL CATHETER. THE SNARE WAS SUCCESSFULLY RETRIEVED, BUT THE REST OF THE PROCEDURE WAS ABORTED AND THE LP REMAINED IMPLANTED. PATIENT WAS STABLE.