CLOVERSNARE¿ 4-LOOP VASCULAR RETRIEVER

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. 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 AN UNKNOWN INFERIOR VENA CAVA (IVC) FILTER, THE PIN VISE CAME OFF OF A CLOVERSNARE 4-LOOP VASCULAR RETRIEVER'S SNARE WIRE. THE PHYSICIAN CAPTURED THE HOOK OF THE NON-COOK FILTER WITH THE SNARE AND PULLED THE SNARE BACK TO LOCK IT IN THE CATHETER. THE TUOHY-BORST WAS TIGHTENED AND THE USER TRIED TO ADVANCE THE CATHETER TO RETRIEVE THE FILTER; HOWEVER, THE PIN VISE POPPED OFF THE BACK OF THE SNARE WIRE. THE SNARE WIRE WAS INSIDE THE TUOHY-BORST ADAPTER, AND BECAUSE THERE WAS NO WIRE OUTSIDE OF THE TUOHY, THE USER HAD TO REMOVE THE SNARE CATHETER TO ACCESS THE SNARE WIRE. THE SAME SYSTEM WAS THEN ADVANCED OVER THE FILTER TO COLLAPSE IT. THE USER REMOVED THE INNER SHEATH, SNARE, AND FILTER TOGETHER, LEAVING THE OUTER 10-FRENCH SHEATH IN PLACE TO PERFORM A POST-PROCEDURE VENOGRAM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE COMPLAINT DEVICE. 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

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED, DURING RETRIEVAL OF AN UNKNOWN INFERIOR VENA CAVA (IVC) FILTER, THE PIN VISE CAME OFF OF A CLOVERSNARE 4-LOOP VASCULAR RETRIEVER'S SNARE WIRE. THE PHYSICIAN CAPTURED THE HOOK OF THE NON-COOK FILTER WITH THE SNARE AND PULLED THE SNARE BACK TO LOCK IT IN THE CATHETER. THE TUOHY-BORST WAS TIGHTENED AND THE USER TRIED TO ADVANCE THE CATHETER TO RETRIEVE THE FILTER; HOWEVER, THE PIN VISE POPPED OFF THE BACK OF THE SNARE WIRE. THE SNARE WIRE WAS INSIDE THE TUOHY-BORST ADAPTER, AND BECAUSE THERE WAS NO WIRE OUTSIDE OF THE TUOHY, THE USER HAD TO REMOVE THE SNARE CATHETER TO ACCESS THE SNARE WIRE. THE SAME SYSTEM WAS THEN ADVANCED OVER THE FILTER TO COLLAPSE IT. THE USER REMOVED THE INNER SHEATH, SNARE, AND FILTER TOGETHER, LEAVING THE OUTER 10-FRENCH SHEATH IN PLACE TO PERFORM A POST-PROCEDURE VENOGRAM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE COMPLAINT DEVICE. 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 G) 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 DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE FOUND, AND THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE INSTRUCTIONS FOR USE (IFU) STATES: ¿EXCESSIVE FORCE SHOULD NOT BE USED TO MANIPULATE OR RETRIEVE FOREIGN OBJECTS.¿ THE INFORMATION PROVIDED UPON REVIEW OF THE COMPLAINT FILE, DMR, DHR, AND IFU SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. BASED ON THE AVAILABLE INFORMATION AND RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A COMPONENT FAILURE UNRELATED TO THE DESIGN OR MANUFACTURING OF THE COMPLAINT DEVICE CAUSED THE INCIDENT. 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.