GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

Description of Event or Problem

AS REPORTED, DURING A PROCEDURE INVOLVING RETRIEVAL OF A COOK TULIP INFERIOR VENA CAVA FILTER, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S SHEATH TORE. THE FILTER HAD BEEN IN PLACE LESS THAN SIX MONTHS AND THERE WERE NO DIFFICULTIES EXPERIENCED CATCHING THE FILTER HOOK. THE INNER SHEATH WOULD NOT ADVANCE OVER THE FILTER, SO THE USER ADVANCED THE OUTER SHEATH. PER THE REPORTER, AS THE USER ATTEMPTED TO RETRIEVE THE FILTER, THE OUTER SHEATH "CRINKLED" ON ITSELF AND UPON REMOVAL FROM THE PATIENT, THE USER NOTED THAT THE SHEATH WAS "VERY CRINKLED" AND THE DISTAL END WAS TORN. THE FILTER WAS UNABLE TO BE RETRIEVED AS THE LEGS WOULD NOT COME LOOSE FROM THE "WALL". THE FILTER WAS LEFT IN PLACE AND THE PATIENT WAS REFERRED TO AN IR PHYSICIAN FOR MORE ADVANCED FILTER REMOVAL TECHNIQUES IN A HOSPITAL SETTING. A SECTION OF THE RETRIEVAL SET DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

Additional Manufacturer Narrative

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.