BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWISTER PLUS

    MDR report key: 4914834 · Received June 25, 2015

    Report

    Report Number
    4914834
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Date of Event
    May 5, 2015
    Report Date
    June 25, 2015
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WE PASSED A TWISTER BASKET TO THE PHYSICIAN TO ASSIST IN REMOVING A BLOOD CLOT FROM THE FUNDUS OF THE STOMACH. THE TWISTER BASKET WOULD NOT OPEN AFTER SEVERAL ATTEMPTS WERE MADE; THE PHYSICIAN MADE SURE THE SCOPE WAS STRAIGHT. IT WAS NOTED THAT THE TWISTER HAD SEPARATED FROM THE BLACK AND TEFLON SHEATH, WHICH WOULD NOT ALLOW THE BASKET TO OPEN. (IT HAD OPENED OK WHEN OUTSIDE OF THE SCOPE.) NO OTHER BASKET WAS AVAILABLE; WE USED A SNARE IN PLACE OF THE BASKET TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411195 TWISTER PLUS SNARE, NON-ELECTRIC FGX BOSTON SCIENTIFIC CORPORATION * H13062401R

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR