BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-THIN SDS BALLOON DILATATION CATHETER

    MDR report key: 1030533 · Received April 17, 2008

    Report

    Report Number
    2134265-2008-01129
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Report Date
    March 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LIT
    PMA / PMN Number
    K952063
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE, A BALLOON DETACHMENT OCCURRED. THE BALLOON SECTION "FELL OFF" THE ULTRA-THIN SDS BALLOON DILATION CATHETER WHEN REMOVING IT FROM THE PACKAGE. THE EVENT OCCURRED OUTSIDE OF THE PT AND THE DEVICE WAS NOT USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-THIN SDS BALLOON DILATATION CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC NA 0009599057

    Patients

    Seq Age Sex Outcome Treatment
    1