inforMED
MalfunctionMMX

BARD SNARE US

Received Jun 23, 2025 · Event occurred May 22, 2025

Report 3008988055-2025-00006 · MDR key 22311792

Device

Generic name

Device, Percutaneous Retrieval

Model number

SP-4094-001

Catalog number

SRK30

Lot number

9017528564

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 PROCEDURE USING A SNARE RETRIEVAL KIT. DURING THE PROCEDURE, THE RADIOPAQUE MARKER ON THE END OF THE CATHETER BROKE LOOSE. IT WAS FURTHER REPORTED THAT BROKEN MARKER FLEW INTO THE PULMONARY ARTERY OF THE PATIENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.