GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
Received Mar 12, 2026 · Event occurred Feb 27, 2026
Report 1820334-2026-00279 · MDR key 24582121
Device
Product problems
- Difficult to Fold, Unfold or Collapse
- Material Split, Cut or Torn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AS REPORTED, DURING RETRIEVAL OF AN UNKNOWN INFERIOR VENA CAVA FILTER, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S SHEATH CRACKED. PER THE REPORTER, THE PROCEDURE WENT WELL AND WAS SUCCESSFUL. UPON REMOVAL OF THE DEVICE FROM THE PATIENT, THE USER NOTED THAT THE SHEATH WAS RIPPED/CRACKED. REPORTEDLY, MEDICAL STAFF SPECULATED THAT ONE OF THE FILTER LEGS RIPPED THE SHEATH. 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 Manufacturer Narrative
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. H3: DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. 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.