BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIB

    MDR report key: 344221 · Received July 27, 2001

    Report

    Report Number
    1318694-2001-00002
    Event Type
    Other
    Date Received
    July 27, 2001
    Date of Event
    June 26, 2001
    Report Date
    July 27, 2001
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    AS PER MW 1022305: "THE BALLOON OF THE CATHETER RUPTURED INSIDE THE VESSEL DURING DEPLOYMENT OF A STENT FOR COARTATION OF THE AORTA".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33868 BIB PTA CATHETER LIT NUMED, INC. 420 BIB-0875

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN