GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

Additional Manufacturer Narrative

SUMMARY OF EVENT: AS REPORTED, DURING RETRIEVAL OF AN UNSPECIFIED INFERIOR VENA CAVA (IVC) FILTER THAT HAD BEEN IN PLACE FOR SIX MONTHS, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S SNARE WIRE SEPARATED. THE USER CAPTURED THE HOOK OF THE UNKNOWN IVC FILTER WITH THE RETRIEVAL SET AND BEGAN TO COLLAPSE THE FILTER INTO THE INNER SHEATH OF THE RETRIEVAL SYSTEM. THE INNER AND OUTER SHEATHS WERE ADVANCED OVER THE FILTER UNTIL THEY REACHED THE FEET OF THE FILTER. THE USER THEN NOTED THAT THE FEET OF THE FILTER WERE EMBEDDED IN THE CAVAL WALL. REPORTEDLY, THE USER "PULLED PRETTY HARD" ON THE DEVICE, AT WHICH POINT THE SNARE WIRE SEPARATED IN HALF AND THE FILTER WAS FREED FROM THE CAVAL WALL. THE PHYSICIAN WAS THEN ABLE TO REMOVE ALL PARTS OF THE FILTER AND RETRIEVAL SET FROM THE PATIENT. A FOLLOW-UP VENOGRAM WAS PERFORMED, WHICH LOOKED "FINE". THERE WAS NO HARM TO THE PATIENT AND NO FOLLOW UP PROCEDURES ARE NEEDED. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER RELATED COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. BECAUSE THERE WERE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: WARNINGS: EXCESSIVE FORCE SHOULD NOT BE EXERTED TO RETRIEVE THE FILTER. A DOCUMENT REVIEW CONCLUDED THAT THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. BASED ON THE AVAILABLE INFORMATION AND RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT UNINTENDED USER ERROR CONTRIBUTED TO THIS FAILURE MODE. THE SNARE LIKELY SNAPPED IN HALF DUE TO EXCESSIVE FORCE USED TO FREE THE FILTER FROM THE IVC. THE IFU WARNS THAT EXCESSIVE FORCE SHOULD NOT BE EXERTED TO RETRIEVE THE FILTER. 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 AN UNSPECIFIED INFERIOR VENA CAVA (IVC) FILTER THAT HAD BEEN IN PLACE FOR SIX MONTHS, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S SNARE WIRE SEPARATED. THE USER CAPTURED THE HOOK OF THE UNKNOWN IVC FILTER WITH THE RETRIEVAL SET AND BEGAN TO COLLAPSE THE FILTER INTO THE INNER SHEATH OF THE RETRIEVAL SYSTEM. THE INNER AND OUTER SHEATHS WERE ADVANCED OVER THE FILTER UNTIL THEY REACHED THE FEET OF THE FILTER. THE USER THEN NOTED THAT THE FEET OF THE FILTER WERE EMBEDDED IN THE CAVAL WALL. REPORTEDLY, THE USER "PULLED PRETTY HARD" ON THE DEVICE, AT WHICH POINT THE SNARE WIRE SEPARATED IN HALF AND THE FILTER WAS FREED FROM THE CAVAL WALL. THE PHYSICIAN WAS THEN ABLE TO REMOVE ALL PARTS OF THE FILTER AND RETRIEVAL SET FROM THE PATIENT. A FOLLOW-UP VENOGRAM WAS PERFORMED, WHICH LOOKED "FINE". THERE WAS NO HARM TO THE PATIENT AND NO FOLLOW UP PROCEDURES ARE NEEDED.

Additional Manufacturer Narrative

AGE: "IN HER 40'S". 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.