BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE?

    MDR report key: 24939779 · Received April 21, 2026

    Report

    Report Number
    2124215-2026-21446
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    March 26, 2026
    Report Date
    May 20, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729806417
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G24PREMARKET / 510(K): K113220, K163174. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION, BUT IT WAS UNABLE TO BE OBTAINED. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED. A 2.50MM X 30MM EMERGE BALLOON CATHETER WAS SELECTED FOR DILATION. HOWEVER, THE BALLOON DID NOT DEFLATE ENTIRELY WHEN PULLING NEGATIVE. THE BALLOON WAS PREPPED AGAIN, AND IT WOULD NOT CROSS THE LESION. THE PROCEDURE WAS THEN COMPLETED USING A DIFFERENT DEVICE, AND IT WORKED FINE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585621 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493918930250 08714729806417

    Patients

    Seq Age Sex Outcome Treatment
    1