BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMERGE?

    MDR report key: 25152968 · Received May 12, 2026

    Report

    Report Number
    2124215-2026-25657
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    March 17, 2026
    Report Date
    May 12, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729806325
    PMA / PMN Number
    K113220
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PMA/510(K): K163174.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA MEDWATCH REPORT THAT A BALLOON RUPTURE OCCURRED, RESULTING IN ADDITIONAL INTERVENTION. THE 95-99% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED MIDDLE LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING INFLATION AT 20 ATMOSPHERES, THE BALLOON RUPTURED DUE TO AN UNFORESEEN CALCIUM SHELF, RESULTING IN BALLOON SHEARING. APPROXIMATELY ONE-HALF TO TWO-THIRDS OF THE BALLOON FRAGMENT REMAINED WITHIN THE CORONARY ARTERY. THE BALLOON SHAFT WAS REMOVED INTACT. A 2.0 X 15MM NON-BOSTON SCIENTIFIC BALLOON WAS THEN INFLATED TO A MAXIMUM OF 12 ATMOSPHERES, AND A STENT WAS PLACED TO ENSURE THE BALLOON FRAGMENTS WERE ENTRAPPED BEHIND THE COVERED STENT, AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS STABLE POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133256 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493918920250 0037357531 08714729806325

    Patients

    Seq Age Sex Outcome Treatment
    1