GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

Additional Manufacturer Narrative

EVENT DATE: "AT LEAST SEVERAL MONTHS AGO." PMA/510(K) NUMBER: K181757. SUMMARY OF EVENT: AS INITIALLY REPORTED, AN "ISSUE" OCCURRED DURING RETRIEVAL OF AN UNKNOWN FILTER WHILE USING A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET. THE FILTER WAS SUCCESSFULLY REMOVED. IT WAS SUGGESTED THAT THE DEVICE MAY NOT HAVE BEEN USED PER THE INSTRUCTIONS FOR USE. 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. INVESTIGATION EVALUATION: THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. THE LOT NUMBER FOR THE COMPLAINT DEVICE WAS NOT PROVIDED. THEREFORE, IT IS UNKNOWN IF THERE WERE ANY NON-CONFORMANCES OR ADDITIONAL COMPLAINTS ON THE LOT. THERE IS NO EVIDENCE TO SUGGEST THAT THE COMPLAINT DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. BASED ON THE LIMITED INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT ALTHOUGH IT IS ASSUMED THAT THE PHYSICIAN HAD TROUBLE CAPTURING THE FILTER, A DEFINITIVE CAUSE FOR THE EVENT CANNOT BE DETERMINED. 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

AS INITIALLY REPORTED, AN "ISSUE" OCCURRED DURING RETRIEVAL OF AN UNKNOWN FILTER WHILE USING A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET. THE FILTER WAS SUCCESSFULLY REMOVED. IT WAS SUGGESTED THAT THE DEVICE MAY NOT HAVE BEEN USED PER THE INSTRUCTIONS FOR USE. 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.