BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 10262952 · Received July 13, 2020

    Report

    Report Number
    3002808486-2020-00709
    Event Type
    Malfunction
    Date Received
    July 13, 2020
    Date of Event
    June 6, 2020
    Report Date
    September 21, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002343105
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: IT TOOK 4 ATTEMPTS TO RELEASE THE IVC FILTER WHEN READY TO DEPLOY. HAD RELEASED SAFETY BUTTON THEN DEPLOYMENT BUTTON IN RECOMMENDED SEQUENCE. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. ACCORDING TO INSTRUCTION FOR USE EXCESSIVE TENSION DURING DEPLOYMENT MAY PREVENT THE FILTER FROM RELEASING WHEN THE RELEASE MECHANISM IS ACTIVATED. BASED ON THE PROVIDED INFORMATION IT IS UNKNOWN WHY THE FILTER WAS PREVENTED FROM BEING RELEASED. HOWEVER, A POSSIBLE CAUSE IS EXCESSIVE TENSION DURING DEPLOYMENT PREVENTED THE FILTER FROM BEING RELEASED IN FIRST ATTEMPT. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. 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

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

    Additional Manufacturer Narrative · 1

    MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. SIMILAR TO DEVICE UNDER PMA/510(K) K171712. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PHYSICIAN MENTIONED THAT IT TOOK 4 ATTEMPTS TO RELEASE THE IVC FILTER WHEN READY TO DEPLOY. HAD RELEASED SAFETY BUTTON THEN DEPLOYMENT BUTTON IN RECOMMENDED SEQUENCE. NO ADVERSE EFFECTS WAS REPORTED ON THE PATIENT DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732795 COOK CELECT PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE E3916408 10827002343105

    Patients

    Seq Age Sex Outcome Treatment
    1