BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    MDR report key: 23177518 · Received September 30, 2025

    Report

    Report Number
    3002808486-2025-00217
    Event Type
    Injury
    Date Received
    September 30, 2025
    Date of Event
    September 24, 2025
    Report Date
    January 29, 2026
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). G4) SIMILAR TO DEVICE MARKETED UNDER 510(K)/PMA: K233680. INVESTIGATION IS STILL IN PROGRESS. 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 · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE CELECT-PT FILTER LEGS BECAME ENTANGLED AND FAILED TO OPEN AFTER ADVANCEMENT FROM JUGULAR APPROACH. THE FILTER WAS REMOVED BY AN UNKNOWN RETRIEVER, AND ANOTHER FILTER WAS SUCCESSFULLY PLACED. THE COMPLAINT REPORTED BY THE USER WAS CONFIRMED. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR SALES REPRESENTATIVE TESTIMONY. A PART OF THE DEVICE AND PHOTOGRAPHIC EVIDENCE WERE RETURNED FOR EVALUATION. THE DEVICE EVALUATION AND THE REVIEW OF THE PHOTOS DETERMINED FOLLOWING: THE FEMORAL INTRODUCER ONLY WAS RETURNED AND WORKED AS INTENDED. THE PHOTOGRAPHS SHOWED THE LOOP OF A RETRIEVAL DEVICE, THE DISTAL TIP OF THE FEMORAL INTRODUCER AND A RELEASED CELECT-PT FILTER. THE SECONDARY FILTER LEGS DID ALL APPEAR IN THE PHOTO, BUT ONLY THREE PRIMARY LEGS. THEREFORE, IT IS ASSUMED THAT TWO OF THEM ARE ENTANGLED, AS REPORTED. A REVIEW OF THE MANUFACTURING RECORDS AND/OR SPECIFICATIONS DID NOT REVEAL ANY DISCREPANCIES/NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE INVESTIGATION CONCLUDES THE COMPLAINT DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE AND/OR LABEL. A CAUSE COULD NOT BE DETERMINED FROM THE INVESTIGATION DUE TO LIMITED INFORMATION TO DETERMINE THE REASON FOR THE FILTER TO FAIL TO OPEN. IMAGING WAS NOT PROVIDED AND THE CELECT-PT FILTER NOR THE JUGULAR INTRODUCER WAS RETURNED. AN INTERNAL ACTION IS NOT DEEMED NECESSARY AT THIS TIME. TRENDING WILL MONITOR IF ANY FUTURE ACTIONS ARE REQUIRED. AFTER CONSIDERING THIS EVENT THE RISK ASSOCIATED WITH THE USE OF THIS DEVICE IS STILL DEEMED ADEQUATE. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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 · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE PATIENT UNDERWENT PLACEMENT OF A FILTER VIA THE INTERNAL JUGULAR VEIN DUE TO BILATERAL FEMORAL VEIN THROMBOSIS. AFTER THE FILTER WAS INVERTED AND DELIVERED INTO THE SHEATH, DURING DEPLOYMENT, THE FILTER'S LEGS BECAME ENTANGLED AND FAILED TO OPEN. SUBSEQUENTLY, A FILTER RETRIEVER WAS USED TO REMOVE THE FILTER, AND A NEW ONE WAS REIMPLANTED. SUBSEQUENTLY, THE FILTER WAS RETRIEVED USING A FILTER RETRIEVER, AND A NEW FILTER WAS IMPLANTED. PATIENT OUTCOME: 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.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305067 COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G35581 E4680191

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female