inforMED
MalfunctionMMX

BARD SNARE OUS

Received Oct 21, 2025 · Event occurred Sep 18, 2025

Report 3008988055-2025-00012 · MDR key 23352111

Device

Generic name

Device, Percutaneous Retrieval

Model number

SP-4094-002

Catalog number

SRK35

Lot number

9018471871

Product problems

  • Mechanical Problem
  • Mechanical Problem

Patient

NA · Unknown

  • Foreign Body In Patient
  • Foreign Body In Patient

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. DEVICE WAS DISCARDED BY USER AND IS NOT AVAILABLE FOR EVALUATION.

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 SNARE LOOP ALLEGEDLY GOT CAUGHT ON THE FILTER LEG. IT WAS FURTHER REPORTED THAT A TIP MARKER FELL INTO THE BLOOD VESSEL. CURRENT STATUS OF THE PATIENT IS UNKNOWN.