BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET

    MDR report key: 10188231 · Received June 24, 2020

    Report

    Report Number
    3002808486-2020-00655
    Event Type
    Malfunction
    Date Received
    June 24, 2020
    Date of Event
    May 5, 2020
    Report Date
    August 12, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE REPORTED EVENT STATES THAT THE FILTER DID NOT DEPLOY. NO HARM OR ADDITIONAL PROCEDURE WAS REPORTED. NO PRODUCT WAS RETURNED FOR INVESTIGATION. 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 PUSH THE RELEASE BUTTON COMPLETELY TO ENSURE PROPER RELEASE OF THE FILTER. BASED ON THE LIMITED INFORMATION PROVIDED AN EXACT CAUSE COULD NOT BE ESTABLISHED, HOWEVER A LIKELY CAUSE COULD BE NOT PRESSING THE RELEASE BUTTON COMPLETELY FOR PROPER RELEASE OF THE FILTER. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THIS TYPE OF DEVICE IS MANUFACTURED TO SPECIFICATIONS. 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): K172557. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "FILTER DID NOT DEPLOY". PATIENT OUTCOME: NO ADVERSE EFFECTS WAS REPORTED ON THE PATIENT DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651531 GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR