inforMED
MalfunctionMMX

BARD SNARE OUS

Received Jul 9, 2025 · Event occurred Jun 11, 2025

Report 3008988055-2025-00007 · MDR key 22459350

Device

Generic name

Device, Percutaneous Retrieval

Model number

SP-4094-002

Catalog number

SRK35

Lot number

9018055229

Product problems

  • Device Dislodged or Dislocated
  • Device Dislodged or Dislocated

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. 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 PROCEDURE USING A SNARE RETRIEVAL KIT. DURING THE PROCEDURE, THE MARK RING AT THE HEAD END OF THE FILTER BECAME DISLODGED. IT WAS FURTHER REPORTED THAT THE FILTER RETRIEVE SYSTEM WAS WITHDRAWN AS A WHOLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.