MalfunctionMMX
BARD SNARE OUS
Received Apr 28, 2025 · Event occurred Mar 14, 2025
Report 3008988055-2025-00004 · MDR key 21920072
Device
Generic name
Device, Percutaneous Retrieval
Manufacturer
Heraeus Medical Components LlcModel number
SP-4094-002Catalog number
SRK35
Lot number
9015010308
Product problems
- Material Split, Cut or Torn
- Material Split, Cut or Torn
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
IT WAS REPORTED THAT DURING A VENA CAVA FILTER RETRIEVAL PROCEDURE, THE SHEATH OR VALVE COMPONENT WAS ALLEGEDLY DETACHED. IT WAS FURTHER REPORTED THAT THERE WAS A DIFFICULTY IN RETRACTING THE DEVICE THRU THE INTRODUCER SHEATH OR REMOVING FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.