BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    MDR report key: 5801613 · Received July 18, 2016

    Report

    Report Number
    3002808486-2016-00748
    Event Type
    Malfunction
    Date Received
    July 18, 2016
    Date of Event
    June 23, 2016
    Report Date
    July 11, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002345048
    PMA / PMN Number
    K121629
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE SIMILAR TO DEVICE WITH 510(K) K121629. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: INVESTIGATION IS BASED SOLELY ON EVENT DESCRIPTION. NO PRODUCT WAS RETURNED AND, THEREFORE, NO CONCLUSION CAN BE DRAWN BASED ON THE INFORMATION PROVIDED REGARDING THE DIFFICULTY OF GETTING THE FILTER BACK INTO THE SHEATH AND THE FILTER NOT OPENING UP, NOR CAN THE ROOT CAUSE BE DETERMINED. THERE IS FOUND 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). CONCOMITANT PRODUCT: IGTCFS-65-2-UNI-CELECT-PT. DEVICE SIMILAR TO DEVICE WITH 510(K) K121629. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "THE FILTER WAS CHANGED FROM FEMORAL TO JUGULAR, AFTER THE FILTER WAS HOOKED, THEY PULLED IT IN THE LOADER/SHEATH. THE LAST 5MM BATTLED TO GET IN. THE FILTER WAS THEN PLACED IN THE IVC BUT DIDN'T OPEN UP. IT WAS RETRIEVED WITH A SNARE. I INVESTIGATED AFTERWARDS AND THE FILTER ALSO AGAIN DIDN'T WANT TO GO IN ALL THE WAY". PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: "THE FILTER WAS CHANGED FROM FEMORAL TO JUGULAR, AFTER THE FILTER WAS HOOKED, THEY PULLED IT IN THE LOADER/ SHEATH. THE LAST 5MM BATTLED TO GET IN. THE FILTER WAS THEN PLACED IN THE IVC BUT DIDN'T OPEN UP. IT WAS RETRIEVED WITH A SNARE. I INVESTIGATED AFTERWARDS AND THE FILTER ALSO AGAIN DIDN'T WANT TO GO IN ALL THE WAY." PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455747 COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE 10827002345048

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention