CLOVERSNARE¿ 4-LOOP VASCULAR RETRIEVER

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED, DURING ATTEMPTED RETRIEVAL OF A COOK CELECT PLATINUM INFERIOR VENA CAVA (IVC) FILTER THAT HAD BEEN IN PLACE FOR ELEVEN MONTHS, A CLOVERSNARE 4-LOOP VASCULAR RETRIEVER WAS UNABLE TO DETACH THE FILTER FEET FROM THE WALL OF THE IVC. THE SNARE WAS USED AND THE RETRIEVAL CATHETER WAS THEN ADVANCED OVER THE FILTER, COVERING THE FILTER WITH THE EXCEPTION OF THE FEET. THE FEET OF THE FILTER, WHICH WERE REPORTEDLY "SECURELY PLANTED", DID NOT DETACH FROM THE WALL OF THE IVC. THE USER PULLED HARD ENOUGH THAT THE FILTER HOOK STRAIGHTENED. THE RETRIEVAL DEVICE WAS REMOVED FROM THE PATIENT, AND THE CATHETER WAS NOTED TO BE ACCORDIONED. THE IMPLANTED FILTER WAS LEFT IN PLACE, AND THE PATIENT WAS REFERRED TO ANOTHER FACILITY FOR MORE ADVANCED FILTER RETRIEVAL TECHNIQUES. 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. A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS ALSO CONDUCTED. THE COMPLAINT DEVICE WAS RETURNED TO COOK FOR INVESTIGATION. THE SNARE WAS LOOPED OVER ITSELF AND THE SHEATH WAS ACCORDIONED NEAR THE PROXIMAL HUB. 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. COOK ALSO REVIEWED THE PRODUCT LABELING, INCLUDING THE INSTRUCTIONS FOR USE (IFU). IT WARNS THE USER ¿EXCESSIVE FORCE SHOULD NOT BE USED TO MANIPULATE OR RETRIEVE FOREIGN OBJECTS.¿ THE INFORMATION PROVIDED UPON REVIEW OF THE RETURNED DEVICE EVALUATION, COMPLAINT FILE, DMR, DHR, AND IFU PROVIDES EVIDENCE THAT 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 UNINTENDED USE ERROR CAUSED THIS INCIDENT. THE USER STATED THAT THE FILTER WAS EMBEDDED INTO THE CAVA WALL AND THAT THEY USED FORCE STRONG ENOUGH TO STRAIGHTEN THE HOOK ON THE FILTER. THE IFU WARNS THE USER TO AVOID EXCESSIVE FORCE WHEN RETRIEVING 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.

Description of Event or Problem

AS REPORTED, DURING ATTEMPTED RETRIEVAL OF A COOK CELECT PLATINUM INFERIOR VENA CAVA (IVC) FILTER THAT HAD BEEN IN PLACE FOR ELEVEN MONTHS, A CLOVERSNARE 4-LOOP VASCULAR RETRIEVER WAS UNABLE TO DETACH THE FILTER FEET FROM THE WALL OF THE IVC. THE SNARE WAS USED AND THE RETRIEVAL CATHETER WAS THEN ADVANCED OVER THE FILTER, COVERING THE FILTER WITH THE EXCEPTION OF THE FEET. THE FEET OF THE FILTER, WHICH WERE REPORTEDLY "SECURELY PLANTED", DID NOT DETACH FROM THE WALL OF THE IVC. THE USER PULLED HARD ENOUGH THAT THE FILTER HOOK STRAIGHTENED. THE RETRIEVAL DEVICE WAS REMOVED FROM THE PATIENT, AND THE CATHETER WAS NOTED TO BE ACCORDIONED. THE IMPLANTED FILTER WAS LEFT IN PLACE, AND THE PATIENT WAS REFERRED TO ANOTHER FACILITY FOR MORE ADVANCED FILTER RETRIEVAL TECHNIQUES.

Additional Manufacturer Narrative

INITIAL REPORTER OCCUPATION = MANAGER. 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.