BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 5972545 · Received September 23, 2016

    Report

    Report Number
    3002808486-2016-01129
    Event Type
    Malfunction
    Date Received
    September 23, 2016
    Report Date
    September 5, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K121629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF# (B)(4). CATALOG # UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AS A COOK CELECT PLATINUM. THE COMPLAINT DEVICE WAS NOT RETURNED, BUT 10 UNOPENED/UNUSED DECEIVES OF 6 DIFFERENT LOT#'S WERE RETURNED. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: IT IS ASSUMED THAT THE COMPLAINT DEVICE IS A CELECT-PT NAVALIGN, SINCE THE ENTIRE RETURNED STOCK IS OF THAT TYPE. HOWEVER, NO IMAGING IS PROVIDED AND THE COMPLAINT DEVICE IS NOT RETURNED, SO IT WOULD BE INAPPROPRIATE TO SPECULATE ON WHAT WENT WRONG. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. IT IS KNOWN FROM THE LITERATURE THAT EXCESSIVE BACK TENSION COULD RESULT IN DEPLOYMENT DIFFICULTIES/FAILURE WHEN PRESSING THE RELEASE BUTTON. THE IFU ADDRESSES THE ISSUE THROUGH THE STATEMENT "WHILE KEEPING SLIGHT BACK TENSION ON THE INTRODUCER, PUSH THE RELEASE BUTTON COMPLETELY TO ENSURE PROPER RELEASE OF THE FILTER" AND THE WARNING "EXCESSIVE TENSION DURING DEPLOYMENT MAY PREVENT THE FILTER FROM RELEASING WHEN THE RELEASE MECHANISM IS ACTIVATED". NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG # UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT COULD BE A GUNTHER TULIP MREYE, GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER OR COOK CELECT PLATINUM. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K000855, K032426, K061815, K073374, K090140, K112119, K121057 OR K121629. (B)(4). INVESTIGATION IS STILL IN PROGRESS

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE FILTER WAS NOT DEPLOYING AFTER THE RELEASE BUTTON WAS PRESSED. EVENTUALLY THE PHYSICIAN WAS ABLE TO DEPLOY THE DEVICE. PATIENT OUTCOME: UNKNOWN AS INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE FILTER WAS NOT DEPLOYING AFTER THE RELEASE BUTTON WAS PRESSED. EVENTUALLY THE PHYSICIAN WAS ABLE TO DEPLOY THE DEVICE. PATIENT OUTCOME: UNKNOWN AS INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624483 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1