CLOVERSNARE¿ 4-LOOP VASCULAR RETRIEVER

Description of Event or Problem

ADDITIONAL INFORMATION WAS RECEIVED 04MAY2022, CLARIFYING THAT THE DEVICE DID NOT MAKE PATIENT CONTACT. THE DEVICE WAS ONLY HANDLED ON THE BACK TABLE PRIOR TO USE. AFTER THE SIDE-ARM SEPARATED, THE DEVICE WAS FURTHER MANIPULATED, RESULTING IN THE STATE IN WHICH IT WAS RETURNED TO COOK (SEPARATED).

Additional Manufacturer Narrative

THERE HAVE BEEN NO CHANGES TO THE INVESTIGATION OR CONCLUSION. 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

THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. DESCRIPTION OF EVENT: AS REPORTED, DURING RETRIEVAL OF AN UNKNOWN INFERIOR VENA CAVA FILTER, THE SIDE PORT SEPARATED FROM A CLOVERSNARE 4-LOOP VASCULAR RETRIEVER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE COMPLAINT DEVICE. UPON RETURN OF THE DEVICE, THE SHAFT OF THE SHEATH WAS ALSO SEPARATED. INVESTIGATION ¿ EVALUATION. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. THE COMPLAINANT RETURNED CLOVERSNARE¿ 4-LOOP VASCULAR RETRIEVER (VRS-6.0-90) TO COOK FOR INVESTIGATION. PHYSICAL EXAMINATION OF THE RETURNED DEVICE SHOWED: THE SHEATH MEASURED APPROXIMATELY 5.9CM FROM THE WHITE HUB. THE SHAFT OF THE SHEATH APPEARS TO HAVE SEPARATED. THE REST OF THE SHAFT WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A DATABASE SEARCH FOR COMPLAINTS ON THE REPORTED LOT FOUND TWO ADDITIONAL COMPLAINTS REPORTED FROM THE FIELD, PR331245 AND PR339098 WITH A DIFFERENT FAILURE. COOK CONCLUDED THAT NO NONCONFORMING PRODUCT FROM THIS LOT EXISTS IN HOUSE OR IN THE FIELD. ALTHOUGH THERE HAS BEEN A TOTAL OF TWO LOT RELATED COMPLAINTS FOR A DIFFERENT FAILURE, THERE IS NO SUSPECTED MANUFACTURING CAUSE OF THIS FAILURE. THERE ARE 100% INSPECTIONS TO CAPTURE THIS FAILURE MODE PRIOR TO DISTRIBUTION AND THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED. AT THIS TIME, COOK CONCLUDED THAT NO NONCONFORMING PRODUCT FROM THIS LOT EXISTS IN HOUSE OR IN THE FIELD. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: PRECAUTIONS: ¿EXCESSIVE FORCE SHOULD NOT BE USED TO MANIPULATE OR RETRIEVE FOREIGN OBJECTS.¿ HOW SUPPLIED: ¿UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT NO DAMAGE HAS OCCURRED.¿ A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. COOK HAS CONCLUDED THAT COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THIS INCIDENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. 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.

Additional Manufacturer Narrative

INITIAL REPORTER OCCUPATION = IR MANAGER. DEVICE EVALUATED BY MFG = OTHER (81) - DEVICE EVALUATION HAS BEGUN; HOWEVER, A CONCLUSION IS NOT YET AVAILABLE. 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 AN UNKNOWN INFERIOR VENA CAVA FILTER, THE SIDE PORT SEPARATED FROM A CLOVERSNARE 4-LOOP VASCULAR RETRIEVER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE COMPLAINT DEVICE. UPON RETURN OF THE DEVICE, THE SHAFT OF THE SHEATH WAS ALSO SEPARATED. 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.