BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE

    MDR report key: 24507310 · Received March 4, 2026

    Report

    Report Number
    2124215-2026-11926
    Event Type
    Malfunction
    Date Received
    March 4, 2026
    Date of Event
    February 10, 2026
    Report Date
    April 2, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729806523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G4: K113220, K163174. INVESTIGATION RESULTS: MEDIA REVIEW: TWO PHOTOS WERE PROVIDED BY THE CUSTOMER, SHOWING THE INNER PACKAGING THE 2.50X8MM EMERGE DEVICE AND A BREAK IN THE HYPOTUBE SHAFT. RETURNED MEDIA CONFIRMS THE REPORTED ALLEGATION. DEVICE ANALYSIS FINDINGS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD (DHR) REVIEW: IT WAS CONFIRMED THAT THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. RISK REVIEW: A RISK REVIEW WAS PERFORMED, AND IT CONFIRMED THAT THE EVENT WAS DEFINED IN THE RISK DOCUMENTATION AND IS RECORDED ACCORDINGLY IN THE PRODUCT RECORD REVIEW TABLE. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: THIS INVESTIGATION IS ASSIGNED A MOST PROBABLE INVESTIGATION CONCLUSION CODE OF UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT AS IT IS MOST LIKELY THAT THE REPORTED EVENT OCCURRED DUE TO AN EXCESSIVE FORCE HAVING BEEN APPLIED TO THE DEVICE. THIS CODE WAS SELECTED AS THE MOST PROBABLE COMPLAINT CAUSE BASED ON THE INFORMATION AVAILABLE. ALTHOUGH THE DEVICE WAS NOT RETURNED FOR ANALYSIS, A PHOTO OF THE DEFECTIVE UNIT WAS PROVIDED BY THE CUSTOMER IN WHICH A BREAK WAS IDENTIFIED ALONG THE HYPOTUBE SHAFT. REPORTED ALLEGATION WAS CONFIRMED. ALTHOUGH THE USER DID NOT SAY AT WHICH STAGE THE SHAFT BROKE, IT IS LIKELY IF OCCURRED DUE TO AN EXCESSIVE FORCE HAVING BEEN APPLIED. AS HIGHLIGHTED WITHIN THE IFU, THE USER IS INSTRUCTED TO HANDLE THE DEVICE WITH CARE DURING DEVICE PREPARATION AND DURING THE PROCEDURE.

    Additional Manufacturer Narrative · 0

    G4: K113220, K163174.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50MM X 8MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS FOUND THAT THE SHAFT BROKE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50MM X 8MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS FOUND THAT THE SHAFT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571871 EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493918908250 0037159567 08714729806523

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown