BARD SNARE RETRIEVAL KIT
Received Nov 10, 2023 · Event occurred Aug 15, 2023
Report 3008988055-2023-00012 · MDR key 18116459
Device
Generic name
Percutaneous Retrieval Device
Manufacturer
Heraeus Medical ComponentsModel number
SP-4094-002Catalog number
SRK35
Lot number
9010939916
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
IT WAS REPORTED THAT DURING A VENA CAVA FILTER RETRIEVAL PROCEDURE, WHEN THE TUNGSTEN-GOLD RING WAS PUSHED OUT OF THE RETRIEVAL CATHETER, THE MARKER BAND ALLEGEDLY FELL ONTO ONE ARM OF THE FILTER. IT WAS FURTHER REPORTED THAT THE FALLEN MARKER BAND ALLEGEDLY COULD NOT BE RETRIEVED WITH OTHER ALTERNATIVE METHODS. REPORTEDLY, GAVE SAFETY EVALUATION AND COMPREHENSIVE CONSIDERATIONS, THE FILTER WAS NOT RETRIEVED FOR THE TIME BEING. THERE WAS NO REPORTED PATIENT INJURY.
Additional Manufacturer Narrative
THE REPORT 3008988055-2023-00012 IS BEING AMENDED TO ADD THE CORRECT INITIAL REPORTER NAME.