BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 14071571 · Received April 11, 2022

    Report

    Report Number
    3002808486-2022-00242
    Event Type
    Malfunction
    Date Received
    April 11, 2022
    Date of Event
    February 4, 2022
    Report Date
    June 28, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002343099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). PMA/510(K): K211875. CORRECTED DATA COMPARED WITH MEDWATCH REPORT (MW5107720): MANUFACTURER NAME: COOK MEDICAL LLC. DEVICE AVAILABLE FOR EVALUATION: YES. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). AFTER INVESTIGATION THE EVENT FOR THIS PR# IS NO LONGER REPORTABLE SUMMARY OF INVESTIGATIONAL FINDINGS: THE FILTER WAS INSERTED, BUT THE FILTER LEGS WERE BRAIDED AND WOULD NOT EXPAND. THE FILTER WAS RETRIEVED AND ANOTHER FILTER WAS PLACED. THE CELECT-PT FILTER WAS RETURNED AND AN EVALUATION FOUND A SECONDARY FILTER LEG CROSSING ITS PRIMARY LEG. HOWEVER, AFTER EASILY REPOSITIONING THE FILTER LEG, THE FILTER WAS FOUND ACCORDING TO SPECIFICATIONS AND COULD BE ATTACHED/DETACHED TO A JUGULAR INTRODUCER WITHOUT DIFFICULTIES. CONSEQUENTLY, THE EXACT REASON FOR THE BRAIDED FILTER LEGS CANNOT BE DETERMINED, BUT THE INSTRUCTIONS FOR USE PROVIDED WITH THE DEVICE WARN NOT TO ROTATE THE EXPANDED FILTER INSIDE THE VENA CAVA BEFORE RELEASE FROM THE JUGULAR INTRODUCER, AS DOING SO MAY COMPROMISE THE PERFORMANCE OF THE FILTER. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. IT WAS ASSESSED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE FINAL RELEASE, THERE IS EVIDENCE THAT THE DHR WAS FULLY EXECUTED. IN ADDITION, NO OTHER LOT RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. IT IS THEREFORE CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS 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

    ACCORDING TO THE INITIAL REPORTER: IVC FILTER INSERTED INTO PATIENT AND WOULD NOT DEPLOY, AND IT WAS FOUND THAT THE TINES WERE BRAIDED. JUGULAR IVC 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
    1580897 COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34309 E4201903 10827002343099

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown