BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET

    MDR report key: 22781329 · Received August 12, 2025

    Report

    Report Number
    3002808486-2025-00179
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    July 25, 2025
    Report Date
    October 3, 2025
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002345017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. 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 FILTER GOT STUCK IN THE DELIVERY SHEATH JUST AFTER THE HUB. UNABLE TO PUSH FORWARD OR RETRACT. REPLACEMENT OF THE FILTER COMPLETED THE PROCEDURE SUCCESSFULLY. THE CELECT-PT FILTER, FEMORAL INTRODUCER, PRE-DILATOR, INTRODUCER DILATOR AND INTRODUCER SHEATH WITH THREE-WAY STOP COCK WAS RETURNED FOR DEVICE EVALUATION. THE EXACT REASON WHY THE FEMORAL INTRODUCER COULD NOT BE ADVANCED THROUGH THE SHEATH CANNOT BE DETERMINED. DURING MANUFACTURING THE FEMORAL INTRODUCER MUST BE ADVANCED THROUGH THE SHEATH TO VERIFY SMOOTH ADVANCEMENT BUT BASED ON THE INVESTIGATION FINDINGS IT IS SUGGESTED THAT THE INTRODUCER SHEATH SOMEHOW KINKED DURING ADVANCEMENT/POSITIONING AND THAT THE KINK PREVENTED ADVANCEMENT OF THE FILTER AND THE FEMORAL INTRODUCER INSIDE. THE SECONDARY LEGS ROTATED THE SAME WAY AROUND COULD BE DUE TO ATTEMPTING TO OVERCOME THE ADVANCEMENT DIFFICULTIES BY ROTATING THE FEMORAL INTRODUCER INSIDE THE INTRODUCER SHEATH AND FINALLY WITHDRAWING, CAUSING THE LEGS TO WRAP UP. THE INSTRUCTIONS FOR USE WARN NOT TO ROTATE THE PRELOADED FILTER INSIDE THE INTRODUCER SYSTEM. REVIEW OF DEVICE MASTER RECORD FOUND DOCUMENTATION ENSURING THE FEMORAL INTRODUCER CAN PASS THROUGH THE INTRODUCER SHEATH WITH CHECK-FLO VALVE BEFORE FINAL RELEASE. REVIEW OF THE DEVICE HISTORY RECORD FOUND THAT ALL DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE RELEASE AND NO INDICATION THAT THE DEVICE WAS PRODUCED OUTSIDE OF SPECIFICATION. IN ADDITION, NO OTHER LOT RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. IT IS THEREFORE CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCTS EXIST IN HOUSE OR IN FIELD. 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 FILTER GOT STUCK IN THE DELIVERY SHEATH JUST AFTER THE HUB. UNABLE TO PUSH FORWARD OR RETRACT. PATIENT OUTCOME: PATIENT WAS FINE THEY JUST USED ANOTHER FILTER.

    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
    1887928 COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34501 E4672598 10827002345017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown