BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT PLATINUM VENA CAVA FILTER SET NAVALIGN

    MDR report key: 23345078 · Received October 21, 2025

    Report

    Report Number
    3002808486-2025-00228
    Event Type
    Injury
    Date Received
    October 21, 2025
    Date of Event
    March 12, 2025
    Report Date
    October 21, 2025
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). AFTER INVESTIGATION THE EVENT IS CONSIDERED REPORTABLE. E1) PHONE NUMBER: (B)(6). G4) SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K233680. SUMMARY OF INVESTIGATIONAL FINDINGS: AS A COOK CELECT-PT FILTER WAS AGAINST THE VESSEL WALL A LOOP TECHNIQUE WAS USED TO REMOVE THE FILTER THREE AND A HALF MONTHS AFTER PLACEMENT, BUT THE RETRIEVAL LOOP BROKE DURING PULLBACK. THE FILTER WAS SUCCESSFULLY REMOVED WITH ANOTHER RETRIEVAL KIT. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR SALES REPRESENTATIVE TESTIMONY. THE DEVICE EVALUATION COULD NOT BE PERFORMED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE OR LABEL. A DEFINITIVE CAUSE COULD NOT BE DETERMINED FROM THE INVESTIGATION. POTENTIAL CAUSES ARE OR MAY INCLUDE FILTER PLACEMENT IN IVCS WITH DIAMETERS LARGER THAN THOSE SPECIFIED IN THESE INSTRUCTIONS FOR USE; IMPROPER DEPLOYMENT; MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER); AND (OR) A FAILED RETRIEVAL ATTEMPT. 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 21CFR 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: DURING REMOVAL OF THE VENA CAVA FILTER (CELECT-PT) DUE TO THE FILTER BEING AGAINST THE VESSEL WALL, A LOOP TECHNIQUE WAS USED TO REMOVE THE FILTER, AND THE RETRIEVAL LOOP WAS BROKEN DURING PULLBACK. THE FILTER WAS REMOVED AGAIN BY REPLACING THE RETRIEVAL KIT INTRAOPERATIVELY. PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999109 COOK CELECT PLATINUM VENA CAVA FILTER SET NAVALIGN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female