CLOVERSNARE¿ 4-LOOP VASCULAR RETRIEVER

Additional Manufacturer Narrative

(B)(6). 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.

Description of Event or Problem

AS REPORTED, DURING RETRIEVAL OF ANOTHER MANUFACTURER'S INFERIOR VENA CAVA FILTER, A CLOVERSNARE 4-LOOP VASCULAR RETRIEVER UNRAVELED AND SEPARATED. THE FILTER WAS PLACED (B)(6) 2022 AND HAD BEEN IN PLACE FOR ALMOST SIX MONTHS AT THE TIME OF RETRIEVAL. IT IS UNKNOWN IF THE FILTER WAS EMBEDDED IN THE CAVAL WALL; HOWEVER, THE FILTER WAS REPORTEDLY VERY DIFFICULT TO COLLAPSE AND RETRIEVE. WHILE ATTEMPTING TO COLLAPSE THE FILTER, THE CLOVERSNARE WIRING SNAPPED AND UNRAVELED INSIDE THE SHEATH. THE FILTER WAS THEN SUCCESSFULLY RETRIEVED WITH A COOK 12-FRENCH SHEATH AND A GOOSENECK SNARE. 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

SUMMARY OF EVENT: AS REPORTED, DURING RETRIEVAL OF ANOTHER MANUFACTURER'S INFERIOR VENA CAVA FILTER, A CLOVERSNARE 4-LOOP VASCULAR RETRIEVER UNRAVELED AND SEPARATED. THE FILTER WAS PLACED 29JUN2022 AND HAD BEEN IN PLACE FOR ALMOST SIX MONTHS AT THE TIME OF RETRIEVAL. IT IS UNKNOWN IF THE FILTER WAS EMBEDDED IN THE CAVAL WALL; HOWEVER, THE FILTER WAS REPORTEDLY VERY DIFFICULT TO COLLAPSE AND RETRIEVE. WHILE ATTEMPTING TO COLLAPSE THE FILTER, THE CLOVERSNARE WIRING SNAPPED AND UNRAVELED INSIDE THE SHEATH. THE FILTER WAS THEN SUCCESSFULLY RETRIEVED WITH A COOK 12-FRENCH SHEATH AND A GOOSENECK SNARE. 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: 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 COULD NOT BE CONDUCTED DUE TO A LACK OF LOT INFORMATION FROM THE USER FACILITY. A REVIEW OF COMPLAINT HISTORY COULD NOT BE CONDUCTED DUE TO A LACK OF LOT INFORMATION FROM THE USER FACILITY. THE INSTRUCTIONS FOR USE (IFU) CAUTIONS ¿EXCESSIVE FORCE SHOULD NOT BE USED TO MANIPULATE OR RETRIEVE FOREIGN OBJECTS.¿ COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION AND THAT THERE ARE NO NON-CONFORMING DEVICES IN-HOUSE OR OUT IN THE FIELD. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR AND THE IFU SUGGESTS THAT THERE IS EVIDENCE 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 EVENT. THE USER REPORTED THAT THE FILTER WAS VERY DIFFICULT TO REMOVE. THE IFU STATES ¿EXCESSIVE FORCE SHOULD NOT BE USED TO MANIPULATE OR RETRIEVE FOREIGN OBJECTS.¿ 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.