BARD SNARE RETRIEVAL KIT
Received Jun 8, 2023 · Event occurred May 27, 2023
Report 3008988055-2023-00004 · MDR key 17090973
Device
Generic name
Percutaneous Retrieval Device
Manufacturer
Heraeus Medical Components, LlcModel number
SP-4094-002Catalog number
SRK35
Lot number
9010023491
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INITIAL REPORTER FULL ADDRESS COULD NOT FIT IN CELL E1 AND IS THE FOLLOWING: (B)(6) 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
THE SNARE RETRIEVAL KIT WAS EXPECTED TO BE USED TO RETRIEVE THE DENALI FILTER PLACED IN THE INFERIOR VENA CAVA THROUGH THE RIGHT INTERNAL JUGULAR VEIN. WHEN PERFORMING RADIOGRAPH WITH THE 11 F INTRODUCER SHEATH OF THE RETRIEVAL KIT, LIQUID WAS FOUND LEAKING THE DISTAL END OF THE INTRODUCER SHEATH. THE SHEATH WAS REMOVED OUT OF THE BODY AND CAREFULLY EXAMINED AND A SMALL "BREACH" WAS FOUND. TO ENSURE THE SAFETY OF THE PATIENT DURING OPERATION, THE SNARE RETRIEVAL KIT WAS REPLACED WITH A NEW ONE.