BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 10188201 · Received June 24, 2020

    Report

    Report Number
    3002808486-2020-00654
    Event Type
    Malfunction
    Date Received
    June 24, 2020
    Report Date
    August 25, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE DEPLOYMENT HOOK WOULD NOT RELEASE FROM THE FILTER HOOK, THE DEVICE HAD TO MANIPULATE TO GET IT TO RELEASE. THE DEVICE WAS LANDED IN TARGET SITE AND POSITION. NO HARM TO PATIENT NO ADVERSE EFFECTS. COOK WAS UNABLE TO CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD, AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED FOR THE INVESTIGATION. ACCORDING TO INSTRUCTION FOR USE EXCESSIVE TENSION DURING DEPLOYMENT MAY PREVENT THE FILTER FROM RELEASING WHEN THE RELEASE MECHANISM IS ACTIVATED. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THIS TYPE OF DEVICE IS MANUFACTURED TO SPECIFICATIONS. BASED ON THE PROVIDED INFORMATION A LIKELY CAUSE IS THAT EXCESSIVE TENSION DURING DEPLOYMENT CONTRIBUTED TO THE REPORTED EVENT. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) K171712. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE DEPLOYMENT HOOK WOULD NOT RELEASE FROM THE FILTER HOOK; THE DEVICE HAD TO MANIPULATE TO GET IT TO RELEASE. THE DEVICE WAS LANDED IN TARGET SITE AND POSITION. PATIENT OUTCOME: NO HARM TO PATIENT NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651945 COOK CELECT PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1