CLOVERSNARE¿ 4-LOOP VASCULAR RETRIEVER

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. INITIAL REPORTER OCCUPATION: "HM3". 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 FILTER, A CLOVERSNARE 4-LOOP VASCULAR RETRIEVER'S SHEATH WAS NOT ABLE TO FULLY CAPTURE THE FILTER. THE CUSTOMER WAS USING THE RETRIEVAL SET FOR THE FIRST TIME AND REPORTEDLY FELT THAT THE DEVICE WAS NOT STURDY ENOUGH. THE ENTIRE SYSTEM WAS USED TO REMOVE THE FILTER, AND BECAUSE THE OUTER SHEATH WAS REMOVED, POST-PROCEDURAL IMAGING WAS NOT POSSIBLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY 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 FILTER, A CLOVERSNARE 4-LOOP VASCULAR RETRIEVER'S SHEATH WAS NOT ABLE TO FULLY CAPTURE THE FILTER. THE CUSTOMER WAS USING THE RETRIEVAL SET FOR THE FIRST TIME AND REPORTEDLY FELT THAT THE DEVICE WAS NOT STURDY ENOUGH. THE ENTIRE SYSTEM WAS USED TO REMOVE THE FILTER, AND BECAUSE THE OUTER SHEATH WAS REMOVED, POST-PROCEDURAL IMAGING WAS NOT POSSIBLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY 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 INFORMATION RECEIVED 23FEB2023. THE FILTER WAS NOT EMBEDDED IN THE CAVAL WALL. AFTER CAPTURING THE FILTER WITH THE SNARE, THE COAXIAL SHEATH SYSTEM WAS ADVANCED WHILE HOLDING THE Y-FITTING STEADY; HOWEVER, THE INNER SHEATH WAS UNABLE TO FULLY CAPTURE THE ANCHORS OF THE FILTER. THEREFORE, THE ENTIRE SYSTEM, INCLUDING THE OUTER SHEATH, WAS USED TO COMPLETELY CAPTURE THE FILTER. 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. THE LOT NUMBER WAS NOT PROVIDED TO COOK, AND A SEARCH OF SALES TO THE CUSTOMER COULD NOT DEFINITIVELY DETERMINE THE LOT NUMBER. THEREFORE, IT IS UNKNOWN IF THERE WERE ANY RELATED NON-CONFORMANCES OR ADDITIONAL COMPLAINTS ON THE LOT. THE PRODUCT IFU INSTRUCTS ¿SEPARATE THE HUB OF THE INNER AND OUTER SHEATHS AND REMOVE INNER SHEATH, SNARE CATHETER, AND FOREIGN OBJECT.¿ THE INFORMATION PROVIDED UPON REVIEW OF THE DMR 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 INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A COMPONENT FAILURE, UNRELATED TO DESIGN OR MANUFACTURING DEFICIENCIES, 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.

Description of Event or Problem

NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

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. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED 23FEB2023. THE FILTER WAS NOT EMBEDDED IN THE CAVAL WALL. AFTER CAPTURING THE FILTER WITH THE SNARE, THE COAXIAL SHEATH SYSTEM WAS ADVANCED WHILE HOLDING THE Y-FITTING STEADY; HOWEVER, THE INNER SHEATH WAS UNABLE TO FULLY CAPTURE THE ANCHORS OF THE FILTER. THEREFORE, THE ENTIRE SYSTEM, INCLUDING THE OUTER SHEATH, WAS USED TO COMPLETELY CAPTURE THE FILTER.