BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC EMERGE

    MDR report key: 16003497 · Received December 19, 2022

    Report

    Report Number
    2124215-2022-53226
    Event Type
    Malfunction
    Date Received
    December 19, 2022
    Date of Event
    December 8, 2022
    Report Date
    December 19, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, THE BALLOON RUPTURED DURING A KISSING BALLOON TECHNIQUE (KBT). THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2554094 NC EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION 7312 0029648323

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown