BARD
Received Nov 1, 2021 · Event occurred Aug 31, 2021
Report 3008988055-2021-00001 · MDR key 12728642
Device
Generic name
Snare Retrieval Kit
Manufacturer
Heraeus Medical Components, Llc.Model number
SRK35Catalog number
SRK35
Lot number
9006545299
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
50 YR · Prefer Not To Disclose
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
DATE OF THIS REPORT (B)(6) 2021
Description of Event or Problem
IT WAS REPORTED THAT A FILTER WAS PLACED IN THE VEIN OF THE LOWER EXTREMITY OF THE PATIENT WHERE THERE WAS THROMBUS. WHEN THE FILTER WAS RETRIEVED WITH THE SNARE RETRIEVAL KIT, THE MARKER FOR VISUALIZATION AT THE PROXIMAL CATHETER OF THE KIT FELL INTO THE POSTCAVA WALL OF THE PATIENT, WHICH COULD NOT BE REMOVED. THE DIRECTOR OF THE HOSPITAL NOTIFIED THE PATIENT OF THIS EVENT AND FUTURE OPERATION WILL DEPEND ON THE CONDITIONS OF THE PATIENT. IT WAS REPORTED THAT DURING A FILTER REMOVAL PROCEDURE, THE MARKER ALLEGEDLY DETACHED. THERE WAS NO REPORTED PATIENT INJURY.