BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT JUGULAR VENA CAVA FILTER SET

    MDR report key: 4878302 · Received June 29, 2015

    Report

    Report Number
    3002808486-2015-00072
    Event Type
    Injury
    Date Received
    June 29, 2015
    Date of Event
    May 15, 2015
    Report Date
    June 3, 2015
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K073374
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG: IGTCFS-65-JUG-CELECT-PERM. INVESTIGATION IS IN PROGRESS. CORRECTIONS COMPARED TO COMPLAINANTS MEDWATCH REPORT (B)(4): DATE OF REPORT: (B)(4) 2015. ADDED THE ADDITIONAL INFORMATION RECEIVED FROM COMPLAINANT ON JUNE 08, 2015. BRAND NAME: COOK CELECT JUGULAR VENA CAVA FILTER SET. COMMON DEVICE NAME: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR. (B)(4). NO MODEL#, EXPIRATION DATE: 09/22/2016. IMPLANT DATE UNKNOWN. DEVICE NOT RECEIVED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO COMPLAINANTS MEDWATCH REPORT (B)(4): PATIENT PRESENTED FOR REMOVAL OF RETRIEVABLE IVC FILTER. DURING REMOVAL IT FELL APART AND PIECES MIGRATED INTO THE PATIENT. ALL PIECES HAVE NOT BEEN RETRIEVED: SOME REMAIN IN THE PATIENT. THE DEVICE WAS BEING RETRIEVED DUE TO THE DEVICE NOT DOING WHAT IT WAS SUPPOSED TO DO. ADDITIONAL INFORMATION RECEIVED FROM COMPLAINANT ON 08 JUNE 2015: THE INITIAL REPORTER INDICATED THAT THE FILTER WAS REMOVED BECAUSE THE PATIENT NO LONGER NEEDED THE FILTER. SHE CONFIRMED THAT THE FILTER DID WHAT IT WAS SUPPOSED TO DO AND THAT THE INITIAL FORM IS INCORRECT. PATIENT OUTCOME: PIECES OF THE BROKEN IVC FILTER REMAINED INSIDE THE PATIENTS BODY. IT IS UNKNOWN IF THE PATIENT UNDERWENT ANY ADDITIONAL PROCEDURES OR EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS AT THIS TIME. INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419245 COOK CELECT JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE E3258107

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other