CLOVERSNARE¿ 4-LOOP VASCULAR RETRIEVER

Additional Manufacturer Narrative

THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

Description of Event or Problem

AS REPORTED, DURING RETRIEVAL OF A CELECT IVC FILTER, A WIRE OF A CLOVERSNARE¿ 4-LOOP VASCULAR RETRIEVER BROKE. THE FILTER WAS IMPLANTED APPROXIMATELY 2 YEARS PREVIOUSLY. ACCESS WAS GAINED THROUGH THE RIGHT JUGULAR VEIN. THE USER WAS ABLE TO HOOK THE FILTER WITH THE CLOVER SNARE. THE USER THEN ADVANCED THE RETRIEVAL SHEATH OVER THE SNARE, BUT AS THEY WERE HOLDING TENSION ON THE SNARE WIRE, THE SNARE WIRE BROKE. THE BROKEN WIRE WAS OUTSIDE THE PATIENT, BUT THE BROKEN WIRE RETRACTED BACK WITHIN THE SNARE CATHETER AND RETRIEVAL SHEATH. THE USER CUT A PORTION OF THE SNARE CATHETER OFF TO RETRIEVE THE BROKEN END OF THE SNARE WIRE. THE USER THEN USED HEMOSTATS TO HOLD THE END OF THE WIRE AND SUCCESSFULLY RETRIEVE THE FILTER AND RETRIEVAL SET FROM THE PATIENT. NO PORTION OF THE DEVICE WAS LEFT WITHIN THE PATIENT. THERE WAS NO NEED WITH ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED, DURING RETRIEVAL OF A CELECT IVC FILTER, A WIRE OF A CLOVERSNARE¿ 4-LOOP VASCULAR RETRIEVER BROKE. THE FILTER WAS IMPLANTED APPROXIMATELY 2 YEARS PREVIOUSLY. ACCESS WAS GAINED THROUGH THE RIGHT JUGULAR VEIN. THE USER WAS ABLE TO HOOK THE FILTER WITH THE CLOVER SNARE. THE USER THEN ADVANCED THE RETRIEVAL SHEATH OVER THE SNARE, BUT AS THEY WERE HOLDING TENSION ON THE SNARE WIRE, THE SNARE WIRE BROKE. THE BROKEN WIRE WAS OUTSIDE THE PATIENT, BUT THE BROKEN WIRE RETRACTED BACK WITHIN THE SNARE CATHETER AND RETRIEVAL SHEATH. THE USER CUT A PORTION OF THE SNARE CATHETER OFF TO RETRIEVE THE BROKEN END OF THE SNARE WIRE. THE USER THEN USED HEMOSTATS TO HOLD THE END OF THE WIRE AND SUCCESSFULLY RETRIEVE THE FILTER AND RETRIEVAL SET FROM THE PATIENT. NO PORTION OF THE DEVICE WAS LEFT WITHIN THE PATIENT. THERE WAS NO NEED WITH ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATION. 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), AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INSPECTION. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS ALSO CONDUCTED. THE COMPLAINANT RETURNED THE VASCULAR RETRIEVAL SNARE COMPONENT OF THE COMPLAINT DEVICE TO COOK FOR INVESTIGATION. PHYSICAL EXAMINATION OF THE RETURNED DEVICE SHOWED THE BLACK SHEATH SEPARATED 11CM FROM THE WHITE CAP AND THE WIRE IS INTACT BUT SEPARATED FROM SHEATH. THE SNARE WIRE IS 98.2CM IN LENGTH AND IT APPEARS THAT THE PROXIMAL END WAS CUT. THE DEVICE HISTORY RECORD (DHR) OF THE REPORTED LOT WAS ALSO REVIEWED AND THERE WERE NO NON-CONFORMANCES RECORDED. A DATABASE SEARCH FOR COMPLAINTS ON THE REPORTED LOT FOUND NO ADDITIONAL LOT RELATED COMPLAINTS FROM THE FIELD. AS THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NON-CONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. THE INVESTIGATION FOUND THAT THE AFFECTED COMPONENT IS SUPPLIED TO COOK FROM AN EXTERNAL SUPPLIER. THE SUPPLIER CONCLUDED THAT THERE IS NO EVIDENCE THAT THE COMPLAINT DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. THERE ARE 100% INSPECTION ACTIVITIES IN PLACE TO IDENTIFY THIS FAILURE PRIOR TO DISTRIBUTION. COOK ALSO REVIEWED THE INSTRUCTIONS FOR USE (IFU) AND THE FOLLOW INFORMATION IS PROVIDED TO THE USER RELATED TO THE REPORTED FAILURE MODE: PRECAUTION: ¿EXCESSIVE FORCE SHOULD NOT BE USED TO MANIPULATE OR RETRIEVE FOREIGN OBJECTS.¿ HOW SUPPLIED: ¿SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED AND UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ COOK HAS CONCLUDED THAT UNINTENDED USER ERROR MAY HAVE CONTRIBUTED TO THIS INCIDENT. 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 NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.