BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE

    MDR report key: 24818940 · Received April 8, 2026

    Report

    Report Number
    2124215-2026-19044
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    March 17, 2026
    Report Date
    May 6, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729806509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PMA/510(K) # FIELD ON 3500A FORM: K113220, K163174.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.00MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON CATHETER BROKE WHILE INSERTING INTO THE SHEATH. THE DEVICE 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
    127967 EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493918908200 0037798925 08714729806509

    Patients

    Seq Age Sex Outcome Treatment
    1