MalfunctionMMX
AVEIR¿ RETRIEVAL SYSTEM CATHETER
Received Oct 20, 2023 · Event occurred Oct 4, 2023
Report 2017865-2023-50315 · MDR key 17981343
Device
Generic name
Device, Percutaneous Retrieval
Manufacturer
St. Jude Medical, Inc.(crm-sylmar)Model number
LSCR111Lot number
8770054
Product problems
- Premature Separation
- Premature Separation
Patient
Unknown
- Embolism/Embolus
- Embolism/Embolus
Narrative
Description of Event or Problem
RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). IT WAS REPORTED THE PATIENT PRESENTED FOR A PACEMAKER REPLACEMENT PROCEDURE. DURING SURGERY, THE LEADLESS PACEMAKER (LP) EXHIBITED HIGH CAPTURE THRESHOLDS AFTER BEING TETHERED. DURING RETRIEVAL OF THE LP, THE SNARE ON THE RETRIEVAL CATHETER LOOSENED AND THE LP MIGRATED TO THE PULMONARY ARTERY. THE LP WAS SUCCESSFULLY EXPLANTED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.