BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA-THIN SDS BALLOON CATHETER

    MDR report key: 790084 · Received December 1, 2006

    Report

    Report Number
    6000089-2006-02516
    Event Type
    Injury
    Date Received
    December 1, 2006
    Report Date
    November 2, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    PMA / PMN Number
    K011889
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS AS OF THE DATE OF THIS REPORT. ADDITIONAL 510K# K011909.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED TREATMENT PROCEDURE, "THE BALLOON BURST WHILE INSIDE OF THE PATIENT. THE TIP HAD TO BE RETRIEVED." FURTHER INFORMATION HAS BEEN REQUESTED ABOUT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-THIN SDS BALLOON CATHETER DQY-CATHETER, PERCUTANEOUS LIT BOSTON SCIENTIFIC CORPORATION NA 8741411

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention