AVEIR¿ RETRIEVAL SYSTEM CATHETER
Received Nov 2, 2023 · Event occurred Oct 12, 2023
Report 2017865-2023-51526 · MDR key 18060463
Device
Generic name
Device, Percutaneous Retrieval
Manufacturer
St. Jude Medical, Inc.(crm-sylmar)Model number
LSCR111Lot number
8933098
Product problems
- Premature Separation
- Premature Separation
Patient
Unknown
- Embolism/Embolus
- Embolism/Embolus
Narrative
Description of Event or Problem
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-51525. IT WAS REPORTED THE PATIENT PRESENTED FOR A LEADLESS PACEMAKER (LP) IMPLANT. DURING THE PROCEDURE AT THE INITIAL LOCATION, AFTER RELEASE, THE LP HAD HIGH CAPTURE THRESHOLDS AND EXHIBITED UNDER SENSING. IT WAS DECIDED TO REPLACE THE DEVICE AND A RETRIEVAL CATHETER WAS OPENED. UPON INITIALLY GRABBING THE LP, THE LP PREMATURELY RELEASED AND MIGRATED TO THE PULMONARY ARTERY. THE LP WAS ABLE TO BE SNARED AND REMOVED FROM THE PATIENT. IMPLANT ATTEMPT WAS ABANDONED. THE PATIENT WAS STABLE.