BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE?

    MDR report key: 25044653 · Received April 30, 2026

    Report

    Report Number
    2124215-2026-23385
    Event Type
    Malfunction
    Date Received
    April 30, 2026
    Date of Event
    April 2, 2026
    Report Date
    May 27, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729806196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER FACILITY NAME: (B)(6) UNIVERSITY. E1: INITIAL REPORTER PHONE: G4: PMA/510(K) # FIELD ON 3500A FORM: K113220, K163174.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON CATHETER BROKE PRIOR TO REACHING THE LESION. THE BALLOON WAS REMOVED AND COMPLETED THE PROCEDURE WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334563 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493918915200 0036934181 08714729806196

    Patients

    Seq Age Sex Outcome Treatment
    1