BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELECT PLATINUM IVC FILTER

    MDR report key: 11010404 · Received December 11, 2020

    Report

    Report Number
    MW5098337
    Event Type
    Injury
    Date Received
    December 11, 2020
    Date of Event
    December 9, 2020
    Report Date
    December 9, 2020
    Manufacturer
    COOK MEDICAL LLC
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CELECT PLATINUM IVCF AFTER 2 FAILED ATTEMPTS AT RETRIEVAL DUE TO TIP EMBEDDING REFERRED FOR FORCEPS RETRIEVAL. ON PRIOR ATTEMPT, 2 OF THE "ARMS" OF THE FILTER HAD BEEN DISTORTED BY THE OPERATOR AND PULLED UPWARD. ONE MONTH LATER, WHEN THE PATIENT WAS BEING IMAGED JUST PRIOR TO FILTER REMOVAL, ONE OF THE "ARMS" WAS NOTED TO HAVE FRACTURED AND MIGRATED TO THE LEFT PULMONARY ARTERY. THE FILTER WAS REMOVED WITH FORCEPS AND THE FRAGMENT WAS ALSO REMOVED. OF NOTE, THE FRACTURE AND EMBOLIZATION MIGHT HAVE BEEN RELATED TO THE PRIOR MANIPULATION, HOWEVER THAT WOULD NOT HAVE HAPPENED HAD THE TIP NOT BEEN SEVERELY EMBEDDED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459404 CELECT PLATINUM IVC FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening| R