BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE?

    MDR report key: 24314530 · Received February 11, 2026

    Report

    Report Number
    2124215-2026-07703
    Event Type
    Malfunction
    Date Received
    February 11, 2026
    Date of Event
    January 20, 2026
    Report Date
    May 14, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729806486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) #: K130391, K163174.

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) #: K130391, K163174.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH A CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 1.20MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BROKE OFF IN THE CORONARY ARTERY. ANOTHER 1.20MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED; BUT THE BALLOON ALSO BROKE OFF IN THE CORONARY ARTERY. THE DEVICES WERE SIMPLY REMOVED FROM THE PATIENT IN ONE PIECE, AND AN ALTERNATE DEVICE WAS THEN USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS EXPECTED TO FULLY RECOVER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH A CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 1.20MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BROKE OFF IN THE CORONARY ARTERY. ANOTHER 1.20MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED; BUT THE BALLOON ALSO BROKE OFF IN THE CORONARY ARTERY. THE DEVICES WERE SIMPLY REMOVED FROM THE PATIENT IN ONE PIECE, AND AN ALTERNATE DEVICE WAS THEN USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS EXPECTED TO FULLY RECOVER. IT WAS FURTHER REPORTED THAT THE BREAK OCCURRED WHILE ATTEMPTING TO CROSS THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41805 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493918908120 0036418373 08714729806486

    Patients

    Seq Age Sex Outcome Treatment
    1