BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    MDR report key: 22641573 · Received July 29, 2025

    Report

    Report Number
    3002808486-2025-00164
    Event Type
    Injury
    Date Received
    July 29, 2025
    Date of Event
    July 9, 2025
    Report Date
    December 9, 2025
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    00827002355811
    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). G4) SIMILAR TO DEVICE MARKETED UNDER 510(K)/PMA: K233680. SUMMARY OF INVESTIGATIONAL FINDINGS: THE CELECT-PT FILTER WOULD NOT RELEASE FROM THE FEMORAL INTRODUCER, WHEN PRESSING THE RELEASE BUTTON. FINALLY, A GÜNTHER TULIP VENA CAVA FILTER RETRIEVAL SET (GTRS) WAS ADVANCED FROM JUGULAR APPROACH AND AFTER CUTTING THE FEMORAL INTRODUCER, THE FILTER AND THE FEMORAL INTRODUCER WAS SUCCESSFULLY REMOVED WITH THE GTRS. NO ADVERSE EVENT TO THE PATIENT REPORTED. 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 THE FOLLOWING: PARTS OF THE RETRIEVAL LOOP SYSTEM WERE RETURNED WITH THE CELECT-PT FILTER AND THE CUT PART OF THE FEMORAL INTRODUCER. ON THE FILTER SOME SECONDARY FILTER LEGS WERE MISPLACED/WRAPPED AROUND OTHER FILTER LEGS. AS THE HANDLE PORTION AND RELEASE MECHANISM OF THE FEMORAL INTRODUCER WERE NOT RETURNED, THE EXACT REASON FOR THE DIFFICULTIES ENCOUNTERED DURING ATTEMPT TO RELEASE THE FILTER CANNOT BE DETERMINED. A REVIEW OF THE MANUFACTURING RECORDS AND/OR SPECIFICATIONS DID NOT REVEAL ANY DISCREPANCIES/NONCONFORMANCE'S 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 DEFINITIVE CAUSE COULD NOT BE DETERMINED FROM THE INVESTIGATION. POSSIBLE CAUSES ARE ROTATION OF PRELOADED FILTER INSIDE THE SHEATH, SHEATH NOT FULLY RETRACTED, WHEN PRESSING THE RELEASE BUTTON, OR THE RELEASE BUTTON WAS NOT COMPLETELY PUSHED. 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: A FILTER WAS PLACED IN THE VENA CAVA, BELOW THE RENAL VEIN. AFTER THE FILTER WAS DELIVERED IN PLACE, THE OUTER SHEATH WAS WITHDRAWN AND THE SECONDARY LEGS OF FILTER WAS DEPLOYED, THE RED BUTTON WAS PRESSED FIRST, THEN THE BLUE BUTTON WAS PRESSED, BUT THE PRIMARY LEG OF THE FILTER COULD NOT BE RELEASED, AND MANY ATTEMPTS WERE MADE TO TRY AND STILL HAD NO EFFECT. FINALLY, THE DOCTOR OPENED A SET OF COOK'S FILTER RETRIEVAL LOOP SYSTEM, FROM THE JUGULAR VEIN APPROACH, HOOK THE FILTER HEAD, CUT THE FILTER DELIVERY SHEATH ROD, WITHDREW THE FILTER ALONG WITH THE DELIVERY SHEATH INTO THE RETRIEVAL SHEATH AND REMOVED IT, AND THEN REPLACED IT WITH A NEW SET OF FILTER, AND THEN PLACED IT AGAIN SUCCESSFULLY. 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
    457042 COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G35581 E4672674 00827002355811

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention