MalfunctionMMX
BARD SNARE OUS
Received Jan 5, 2026 · Event occurred Dec 1, 2025
Report 3008988055-2026-00001 · MDR key 23968892
Device
Generic name
Device, Percutaneous Retrieval
Manufacturer
Heraeus Medical Components LlcModel number
SP-4094-002Catalog number
SRK35
Lot number
9017746423
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OR ADMISSION THAT THE DEVICE HAS MALFUNCTIONED OR THAT THE DEVICE WAS RELATED TO A DEATH OR INJURY.
Description of Event or Problem
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER RETRIEVAL USING A SNARE RETRIEVAL KIT. DURING THE PROCEDURE, THE FLUID WAS ALLEGEDLY LEAKING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.