MalfunctionMMX
BARD SNARE DUAL SHEATH SNARE KIT, 20 MM
Received Mar 23, 2022 · Event occurred Feb 24, 2022
Report 3008988055-2022-00002 · MDR key 13867934
Device
Generic name
Device, Percutaneous Retrieval
Manufacturer
Heraeus Medical ComponentsModel number
SP-4094-001Catalog number
SRK30
Lot number
9007027211
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A FILTER RETRIEVAL PROCEDURE, THE DEVICE ALLEGEDLY BROKE OFF IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.
Additional Manufacturer Narrative
THEY WERE ABLE TO RETRIEVE THE FILTER BUT NOT THE CATHETER TIP ON THE SNARE REMOVAL DEVICE THAT BROKE OFF. THE TIP WAS LEFT IN THE PATIENT AS THERE WAS NO VIABLE WAY TO RETRIEVE IT. I HAVE NOT RECEIVED AN UPDATE FROM THE CUSTOMER BUT WILL CHECK IF THERE WAS ANY FOLLOW UP.