BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMERGE?

    MDR report key: 25220447 · Received May 19, 2026

    Report

    Report Number
    2124215-2026-26899
    Event Type
    Injury
    Date Received
    May 19, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 19, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729806103
    PMA / PMN Number
    K113220
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 PREMARKET / 510(K): K113220, K163174.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED REQUIRING ADDITIONAL INTERVENTION. A 2.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED, AND A PORTION OF IT REQUIRED STENTING TO THE SIDE OF THE VESSEL. THE PROCEDURE WAS THEN COMPLETED USING AN ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487598 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493918912250 0038014102 08714729806103

    Patients

    Seq Age Sex Outcome Treatment
    1