BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE

    MDR report key: 20800552 · Received November 27, 2024

    Report

    Report Number
    2124215-2024-74651
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    November 1, 2024
    Report Date
    November 27, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729806455
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT WAS ESTIMATED BASED ON AWARE DATE AS THE EVENT DATE WAS NOT PROVIDED. G4 PREMARKET/510(K) # K113220, K163174.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BALLOON ISSUE OCCURRED. THE 3.50 X 30 MM EMERGE MR BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON DEFLATION SEEMED SLOW. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878095 EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493918930350 08714729806455

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown