CLOVERSNARE 4-LOOP VASCULAR RETRIEVER
Received May 29, 2026 · Event occurred May 11, 2026
Report 1820334-2026-00574 · MDR key 25334562
Device
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
Description of Event or Problem
AS REPORTED, DURING RETRIEVAL OF AN UNKNOWN INFERIOR VENA CAVA FILTER, THE PIN VISE CAME OFF OF A CLOVERSNARE 4-LOOP VASCULAR RETRIEVER¿S SNARE. THE USER TIGHTENED THE PIN VISE ON THE SNARE PRIOR TO USE; HOWEVER, THE PIN VISE CAME OFF WHEN ¿A LOT OF FORCE¿ WAS USED TO SNARE THE FILTER. A KELLY CLAMP WAS USED IN PLACE OF THE PIN VISE, AND THE PROCEDURE WAS CONTINUED. REPORTEDLY, THERE WAS NO IMPACT TO THE PATIENT OR THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.