GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED, DURING RETRIEVAL OF ANOTHER MANUFACTURER'S INFERIOR VENA CAVA FILTER, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S OUTER SHEATH SPLIT. THE INNER SHEATH WOULD NOT TRACK OVER THE FILTER, SO THE USER PUSHED THE OUTER SHEATH OVER THE FILTER, AT WHICH POINT THE OUTER SHEATH SPLIT. THE USER REPORTEDLY BELIEVES THAT THE HOOK OF THE FILTER SLICED THE OUTER SHEATH, AS THE FILTER WAS TILTED. PHOTOS PROVIDED BY THE CUSTOMER SHOW THAT THE OUTER SHEATH IS SPLIT AND THERE IS POSSIBLE SCRATCHING/DAMAGE TO THE INNER SHEATH. A NEW RETRIEVAL SET WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. CORRECTED INFORMATION: H6 (ANNEX A AND G) INVESTIGATION EVALUATION: REVIEWS OF THE MANUFACTURING INSTRUCTIONS, QUALITY CONTROL PROCEDURES, AND THE INSTRUCTIONS FOR USE (IFU) WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION; HOWEVER, PHOTOS PROVIDED BY THE CUSTOMER SHOW THAT PART OF THE BLUE OUTER SHEATH WAS SPLIT OPEN FROM THE TIP, APPROXIMATELY 5 CENTIMETERS UP, AND THE BLACK INNER SHEATH WAS DAMAGED AT THE TIP. COOK COULD NOT COMPLETE A REVIEW OF THE DEVICE HISTORY RECORD OR COMPLAINT HISTORY DUE TO A LACK OF LOT INFORMATION FROM THE USER FACILITY. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: INTENDED USE: THE PRODUCT HAS BEEN DESIGNED FOR RETRIEVAL OF IMPLANTED GUNTHER TULIP VENA CAVA FILTERS AND COOK CELECT VENA CAVA FILTERS IN PATIENT WHO NO LONGER REQUIRE A FILTER. RETRIEVAL OF THE FILTER CAN BE PERFORMED ONLY BY JUGULAR APPROACH. WARNINGS: EXCESSIVE FORCE SHOULD NOT BE EXERTED TO RETRIEVE THE FILTER. INSTRUCTIONS FOR USE- FILTER RETRIEVAL: WHILE HOLDING THE RETRIEVAL LOOP AND Y-FITTING STEADY, ADVANCE THE SIDE-ARM FITTING TO COLLAPSE THE FILTER INTO THE COAXIAL RETRIEVAL SHEATH AND DISENGAGE THE ANCHORS OF THE FILTER FROM THE CAVAL WALL. CAUTION: DO NOT RETRACT THE RETRIEVAL LOOP SYSTEM AT THIS STEP. DOING SO MAY CAUSE DAMAGE TO THE CAVAL WALL. WHEN THE TIP OF THE COAXIAL RETRIEVAL SHEATH IS AT THE FILTER ANCHORS, LOOSEN THE HUB OF THE OUTER SHEATH AND ADVANCE THE OUTER SHEATH FORWARD TO COVER THE ENTIRE FILTER. WARNING: SPECIFIC FOR THE GUNTHER TULIP VENA CAVA FILTER: DO NOT ADVANCE THE INNER SHEATH OVER THE ANCHORS OF THE FILTER; DOING SO MAY CAUSE PARTICLES TO SCRATCH OFF THE SHEATH. CAUTION: ENSURE THAT THE ENTIRE FILTER IS COVERED BY THE OUTER SHEATH TO PREVENT THE FILTER ANCHORS FROM DAMAGING THE CAVAL WALL. A DOCUMENT REVIEW CONCLUDED THAT THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THIS TYPE OF DEVICE IS MANUFACTURED TO SPECIFICATIONS. COOK HAS CONCLUDED THAT THIS DEVICE WAS MANUFACTURED TO SPECIFICATION. BASED ON THE AVAILABLE INFORMATION AND RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THE OUTER SHEATH LIKELY SPLIT OPEN BECAUSE THE FILTER WAS NOT SUFFICIENTLY COLLAPSED BEFORE THE OUTER SHEATH WAS ADVANCED. THE DEVICE WAS ALSO USED TO RETRIEVE ANOTHER MANUFACTURER'S FILTER. THE IFU FOR THE GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET STATES THAT THE DEVICE IS INTENDED FOR RETRIEVAL OF COOK GUNTHER TULIP AND CELECT VENA CAVA FILTERS. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. 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

NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

Description of Event or Problem

AS REPORTED, DURING RETRIEVAL OF ANOTHER MANUFACTURER'S INFERIOR VENA CAVA FILTER, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S OUTER SHEATH SPLIT. THE INNER SHEATH WOULD NOT TRACK OVER THE FILTER, SO THE USER PUSHED THE OUTER SHEATH OVER THE FILTER, AT WHICH POINT THE OUTER SHEATH SPLIT. THE USER REPORTEDLY BELIEVES THAT THE HOOK OF THE FILTER SLICED THE OUTER SHEATH, AS THE FILTER WAS TILTED. PHOTOS PROVIDED BY THE CUSTOMER SHOW THAT THE OUTER SHEATH IS SPLIT AND THERE IS POSSIBLE SCRATCHING/DAMAGE TO THE INNER SHEATH. A NEW RETRIEVAL SET WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

Additional Manufacturer Narrative

PMA/510(K) NUMBER = K181757. 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.