5F PRELUDE SHEATH INTRODUCER
Received Jul 1, 2026 · Event occurred Feb 23, 2026
Report 1721504-2026-00272 · MDR key 25680661
Device
Generic name
Dilator, Vessel, For Percutaneous Catheterization
Manufacturer
Merit Medical Systems Inc.Catalog number
PSI-5F-11-038
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Aneurysm
Narrative
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE ESTABLISHED. A REVIEW OF THE PRODUCT HISTORY AND COMPLAINT DATABASE COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED. NONCONFORMANCES OF THIS NATURE ARE MONITORED BY THE OPERATION TEAM.
Additional Manufacturer Narrative
THE SUSPECT DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. FOLLOW UP WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED.
Description of Event or Problem
CUSTOMER REPORTS THE PATIENT EXPERIENCED A PSEUDOANEURYSM AFTER A PULSE FIELD ABLATION (PFA) PROCEDURE USING A FARADRIVE SHEATH. AN UNSPECIFIED MEDICAL INTERVENTION WAS PERFORMED. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN. THIS EVENT WAS DISCOVERED WHILE REVIEWING THE MAUDE DATABASE. THE EVENT IS BEING CONSERVATIVELY REPORTED DUE TO THE PSEUDOANEURYSM AS IT IS POSSIBLE THE MERIT DEVICE WAS INVOLVED ALTHOUGH THE REPORTED EVENT ONLY SPECIFIES THE FARADRIVE SHEATH.