GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
Received Jul 9, 2026
Report 1820334-2026-00726 · MDR key 25764509
Device
Product problems
- Material Perforation
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E3: INVENTORY COORDINATOR. 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.
Description of Event or Problem
AS REPORTED, AN UNSPECIFIED FILTER ¿CAME OUT¿ OF A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S SHEATH WHILE STILL IN THE BODY. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AFTER THE PROCEDURE, WHICH CONFIRMED THAT THERE WAS NO DAMAGE OR HARM TO THE PATIENT. THERE HAS BEEN NO REPORT THAT THE PATIENT REQUIRED ADDITIONAL PROCEDURES OR EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.