BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 7305539 · Received March 1, 2018

    Report

    Report Number
    3002808486-2018-00302
    Event Type
    Malfunction
    Date Received
    March 1, 2018
    Report Date
    April 11, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K090140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). D4) CATALOG# IGTCFS-65-1-JUG-TULIP G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. (B)(4). INVESTIGATION: INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE OPERATIVE NOTE STATING 'TULIP, PAIN, UNABLE TO RETRIEVE (RECORDS SHOW IT WAS RETRIEVED FINE)'. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. LOT# IS UNKNOWN, BUT THE DEVICE (IGTCFS-65-1-JUG-TULIP) AND TULIP FILTER ARE MANUFACTURED AND INSPECTED ACCORDING TO 1000340MI (DEVICE MI), 1001721QC (DEVICE QCI), A41935 (TULIP MI), AND A41936 (TULIP QCI). NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: IT IS ALLEGED THAT "[PT] RECEIVED A IGTCFS-65-1-JUG-TULIP ON (B)(6) 2010". IT IS ALLEGED THAT "DEVICE IS UNABLE TO RETRIEVED". PATIENT OUTCOME: ALLEGED "PAIN AND CAN HARDLY WALK."

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016032E LOT. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    THIS ADDITIONAL INFORMATION RECEIVED ON 6FEB2018 AS FOLLOWS: ¿[PT] ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2010 VIA THE SMALL JUGULAR VEIN DUE TO INCREASED RISK FOR DEEP VEIN THROMBOSIS AND PULMONARY EMBOLI GIVEN LIMITED MOBILITY AND MORBID OBESITY. FILTER WAS SUCCESSFULLY REMOVED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149670 GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR