BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE?

    MDR report key: 23404550 · Received October 28, 2025

    Report

    Report Number
    2124215-2025-77256
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 8, 2025
    Report Date
    December 19, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729806103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4. PREMARKET / 510(K) #: K113220, K163174 DEVICE EVALUATED BY MFR: FG EMERGE MR, US 2.50MM X 12MM WAS RETURNED FOR ANALYSIS. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND MULTIPLE KINKS ALONG THE SHAFT. A VISUAL AND TACTILE EXAMINATION OF THE OUTER LUMEN AND MID-SHAFT SECTION FOUND NO ISSUES, AND A MICROSCOPIC EXAMINATION IDENTIFIED THAT THE INNER LUMEN WAS BUNCHED AND STRETCHED AT 19CM FROM THE PORT EXCHANGE. FURTHER STRETCHING WAS IDENTIFIED ALONG THE INNER LUMEN, RESULTING IN THE PROXIMAL SECTION OF THE BALLOON BEING PULLED PROXIMALLY AWAY FROM THE PROXIMAL MARKERBAND. A VISUAL, TACTILE AND MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL IDENTIFIED A COMPLETE CIRCUMFERENTIAL BALLOON TEAR 8MM FROM PROXIMAL BALLOON SLEEVE. THE DISTAL SECTION OF THE BALLOON TEAR WAS PULLED OUT OVER THE TIP OF THE DEVICE. A VISUAL EXAMINATION OF THE TIP SHOWED NO SIGNS OF DAMAGE. A MICROSCOPIC EXAMINATION OF THE PROXIMAL AND DISTAL MARKERBANDS IDENTIFIED NO DAMAGE. AN EXAMINATION ON THE INNER/WIRE LUMEN IDENTIFIED THAT THE INNER WAS STRETCHED AND AS A RESULT A 0.014-INCH WIRE COULD NOT LOAD THROUGH THE INNER/WIRE LUMEN.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED WITHIN A HEAVILY CALCIFIED SEGMENT. A 2.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INITIAL INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITH NO FRAGMENTS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED WITHIN A HEAVILY CALCIFIED SEGMENT. A 2.50 MM X 12 MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INITIAL INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITH NO FRAGMENTS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2028108 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493918912250 0036972362 08714729806103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown