BARD SNARE RETRIEVAL KIT
Received Feb 23, 2024 · Event occurred Jan 16, 2024
Report 3008988055-2024-00001 · MDR key 18773495
Device
Generic name
Percutaneous Retrieval Device,
Manufacturer
Heraeus Medical Components LlcModel number
SP-4094-001Catalog number
SRK30
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
NA · Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
THE REPORT 3008988055-2024-00001 IS BEING AMENDED TO ADD THE CORRECT THE INITIAL REPORTER NAME.
Description of Event or Problem
IT WAS REPORTED THAT DURING FILTER REMOVAL PLACEMENT PROCEDURE, THE MARKER BAND BROKE OFF OF THE 9F SHEATH. IT WAS FURTHER REPORTED THAT THE MARKER BAND UNABLE TO GET THE MARKER BAND OUT OF THE BODY. THERE WAS NO REPORTED PATIENT INJURY.
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.