CLOVERSNARE 4-LOOP VASCULAR RETRIEVER

Additional Manufacturer Narrative

SUMMARY OF EVENT: AS REPORTED, A CLOVERSNARE 4-LOOP VASCULAR RETRIEVER WAS USED FOR ATTEMPTED RETRIEVAL OF A COOK CELECT FILTER. THE FILTER HAD BEEN IN PLACE SINCE (B)(6) 2025, AND THE FEET/LEGS OF THE FILTER WERE EMBEDDED IN THE CAVAL WALL. DURING ATTEMPTED RETRIEVAL OF THE FILTER, THE HOOK OF THE FILTER STRAIGHTENED OUT, MAKING RETRIEVAL IMPOSSIBLE WITH THE CLOVERSNARE. BECAUSE RETRIEVAL WAS UNSUCCESSFUL, THE PROCEDURE WAS ABORTED AND THE FILTER REMAINED IN THE PATIENT; HOWEVER, IT WAS LATER RETRIEVED DURING AN ADDITIONAL COMPLEX FILTER RETRIEVAL PROCEDURE, USING ANOTHER CLOVER SET AND A 16-FRENCH SHEATH. THE FILTER WAS ¿GRABBED BY THE HEAD¿ WITH THE SNARE AND COLLAPSED WITH THE 16-FRENCH SHEATH. THE PATIENT WAS NOT HOSPITALIZED AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. THE COMPLAINT ON THE COOK CELECT FILTER WAS REPORTED BY WILLIAM COOK EUROPE. INVESTIGATION EVALUATION: REVIEWS OF THE 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; HOWEVER, THE USED FILTER (COOK CELECT - WILLIAM COOK EUROPE) WAS RETURNED TO COOK. THE HOOK OF THE FILTER WAS STRAIGHTENED OUT. THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER TO COOK, AND A SEARCH OF SALES WAS UNABLE TO DEFINITIVELY DETERMINE THE LOT; THEREFORE, THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE REVIEWED. THE PRODUCT IFU CAUTIONS ¿EXCESSIVE FORCE SHOULD NOT BE USED TO MANIPULATE OR RETRIEVE FOREIGN OBJECTS.¿ A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, IFU, AND INSPECTION OF THE FILTER (COOK CELECT - WILLIAM COOK EUROPE) SUGGESTS THAT THERE IS EVIDENCE THE COMPLAINT DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT PROCEDURAL ISSUES CONTRIBUTED TO THIS EVENT. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED, AND NO ADDITIONAL ESCALATION WAS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED, AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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.

Additional Manufacturer Narrative

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, A CLOVERSNARE 4-LOOP VASCULAR RETRIEVER WAS USED FOR ATTEMPTED RETRIEVAL OF A COOK CELECT FILTER. THE FILTER HAD BEEN IN PLACE SINCE ON (B)(6) 2025, AND THE FEET/LEGS OF THE FILTER WERE EMBEDDED IN THE CAVAL WALL. DURING ATTEMPTED RETRIEVAL OF THE FILTER, THE HOOK OF THE FILTER STRAIGHTENED OUT, MAKING RETRIEVAL IMPOSSIBLE WITH THE CLOVERSNARE. BECAUSE RETRIEVAL WAS UNSUCCESSFUL, THE PROCEDURE WAS ABORTED AND THE FILTER REMAINED IN THE PATIENT; HOWEVER, IT WAS LATER RETRIEVED DURING AN ADDITIONAL COMPLEX FILTER RETRIEVAL PROCEDURE, USING ANOTHER CLOVER SET AND A 16-FRENCH SHEATH. THE FILTER WAS ¿GRABBED BY THE HEAD¿ WITH THE SNARE AND COLLAPSED WITH THE 16-FRENCH SHEATH. THE PATIENT WAS NOT HOSPITALIZED AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. THE COMPLAINT ON THE COOK CELECT FILTER WILL BE REPORTED BY WILLIAM COOK EUROPE.