BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPRESS®.BRAIDED CATHETER

    MDR report key: 11813236 · Received May 12, 2021

    Report

    Report Number
    3010665433-2021-00028
    Event Type
    Injury
    Date Received
    May 12, 2021
    Date of Event
    April 28, 2021
    Report Date
    April 29, 2021
    Product Code
    DQO
    UDI-DI
    00884450032565
    PMA / PMN Number
    K053171
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS BEEN RETURNED FOR EVALUATION. THE DEVICE WAS EXAMINED VISUALLY, AND FUNCTIONAL TESTING WAS PERFORMED. THE COMPLAINT IS CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED HOWEVER, IT IS LIKELY THAT SIGNIFICANT FORCE WAS APPLIED TO THE DEVICE DURING CLINICAL USE. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR PROCEDURE THE CATHETER TIP OF A 5F RBI CATHETER DETACHED WITHIN THE PATIENT'S ANATOMY. A VASCULAR SNARE DEVICE WAS USED TO SUCCESSFULLY RETRIEVE THE FOREIGN BODY FORM THE PATIENT. NO ADDITIONAL CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710805 IMPRESS®.BRAIDED CATHETER DEVICE NAME CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO E2012755 00884450032565

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDEWIRE| GUIDEWIRE