BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE?

    MDR report key: 24456299 · Received February 26, 2026

    Report

    Report Number
    2124215-2026-10676
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    February 5, 2026
    Report Date
    April 7, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729806271
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 PMA/510(K): K113220, K163174.

    Additional Manufacturer Narrative · 0

    G4 PMA/510(K): K113220, K163174 INVESTIGATION RESULTS: DEVICE ANALYSIS FINDINGS: THE DEVICE WAS DISPOSED AND WILL NOT BE RETURN FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD REVIEW: THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE 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. 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 CAUSE NOT ESTABLISHED. THIS CODE WAS SELECTED AS THE MOST PROBABLE COMPLAINT CAUSE BASED ON THE INFORMATION AVAILABLE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS, AND NO IMAGE OR PROCEDURAL MEDIA WAS RECEIVED FROM THE CUSTOMER. CLARIFICATION INFORMATION WAS REQUESTED FORM THE CUSTOMER REGARDING THE REPORTED EVENT HOWEVER, NO NEW INFORMATION WAS RECEIVED. BASED ON THE AVAILABLE INFORMATION A CLEAR CONCLUSION FOR THE REPORTED EVENT CANNOT BE ESTABLISHED, NOR CAN THE ALLEGATION BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON DAMAGE OCCURRED. THE 4.00MM X 15MM EMERGE MR BALLOON CATHETER WAS SELECTED FOR USE. DURING AN ATTEMPT TO ADVANCE THE BALLOON OVER THE BACK END OF A NON-BOSTON SCIENTIFIC GUIDEWIRE, THE WIRE EXITED THROUGH THE BALLON. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON DAMAGE OCCURRED. THE 4.00MM X 15MM EMERGE MR BALLOON CATHETER WAS SELECTED FOR USE. DURING AN ATTEMPT TO ADVANCE THE BALLOON OVER THE BACK END OF A NON-BOSTON SCIENTIFIC GUIDEWIRE, THE WIRE EXITED THROUGH THE BALLON. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525279 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493918915400 0034941775 08714729806271

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male 0.014 ABBOTT BMW UNIVERSAL GUIDEWIRE.| 0.014 ABBOTT BMW UNIVERSAL GUIDEWIRE.