BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE?

    MDR report key: 21938291 · Received April 30, 2025

    Report

    Report Number
    2124215-2025-25821
    Event Type
    Malfunction
    Date Received
    April 30, 2025
    Date of Event
    April 1, 2025
    Report Date
    April 30, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729806233
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 - PREMARKET: K163174.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00MM X 15MM EMERGE? BALLOON CATHETER WAS USED AS A TRAPPING BALLOON INSIDE THE GUIDE CATHETER TO EXCHANGE A WIRE FOR A MICRO CATHETER OUT OF THE BODY. UPON REMOVAL OF THE BALLOON IN A DEFLATED STATE, IT WAS NOTICED THAT THE BALLOON WAS NO LONGER ON THE BALLOON CATHETER. THE GUIDEWIRE, GUIDE CATHETER, AND BOSTON SCIENTIFIC GUIDEZILLA EXTENSION CATHETER WERE PULLED OUT TOGETHER UNDER FLUOROSCOPY TO VERIFY THAT NO FOREIGN BODIES WERE LEFT IN THE PATIENT. AFTER IT WAS INSPECTED, THE WHOLE MISSING BALLOON WAS FOUND INSIDE THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS STABLE POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2184808 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493918915300 0035028624 08714729806233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown