GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

Additional Manufacturer Narrative

CORRECTED INFORMATION: B1, H1, H6 ANNEX A AND ANNEX G UPON RETURN AND EVALUATION OF THE DEVICE, THE HUB OF THE BLUE SHEATH (OUTER SHEATH) WAS SEPARATED. THE SHEATH SHAFT WAS NOT SEPARATED. PER A SEARCH OF RISK DOCUMENTATION AND PREVIOUS COMPLAINT DATA, THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE FAILURE (HUB SEPARATION) WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR A SERIOUS INJURY IF THE FAILURE WERE TO RECUR. FURTHERMORE, THERE IS NO EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY, AS NO LIFE-THREATENING OR PERMANENTLY IMPAIRING INJURY WAS ALLEGED, NOR WAS INTERVENTION TAKEN AS A RESULT OF THE DEVICE FAILURE WHICH WOULD BE REQUIRED TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE TO THE PATIENT. AS SUCH, THE EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803 AS IT DOES NOT MEET THE CRITERIA FOR A DEATH, SERIOUS INJURY, OR REPORTABLE PRODUCT MALFUNCTION. 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 A PROCEDURE INVOLVING RETRIEVAL OF ANOTHER MANUFACTURER'S INFERIOR VENA CAVA FILTER, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET¿S ¿BLUE PART¿ (SHEATH) ¿BROKE APART¿. A SECOND GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET WAS USED; HOWEVER, THE SAME THING HAPPENED (THE SECOND DEVICE WILL BE REPORTED UNDER PATIENT IDENTIFIER 447445). THERE WAS NO "OBVIOUS" TORTUOSITY. A DIFFERENT SNARE AND FORCEPS WERE THEN USED TO SUCCESSFULLY REMOVE THE FILTER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT WAS NOT HOSPITALIZED AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4: PMA/510(K) NUMBER = K222254. 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.