MalfunctionMMX
BARD SNARE OUS
Received Oct 7, 2025 · Event occurred Sep 4, 2025
Report 3008988055-2025-00011 · MDR key 23240163
Device
Generic name
Device, Percutaneous Retrieval
Manufacturer
Heraeus Medical Components LlcModel number
SP-4094-002Catalog number
SRK35
Lot number
9018090644
Product problems
- Material Integrity Problem
- Material Integrity Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- 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 RETRIEVAL, THE SNARE ALLEGEDLY FRACTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.