BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMERGE?

    MDR report key: 23200937 · Received October 2, 2025

    Report

    Report Number
    2124215-2025-68314
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    June 20, 2025
    Report Date
    October 29, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729806417
    PMA / PMN Number
    K113220
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) #: K163174. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) #: K163174. B5. DESCRIBE EVENT OR PROBLEM UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED REQUIRING UNEXPECTED MEDICAL INTERVENTION. A 2.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING CIRCUMFLEX CORONARY ANGIOPLASTY, THE DISTAL BALLOON CATHETER WAS COMPLETELY DETACHED AND MIGRATED INTO THE CORONARY ARTERY. THE DETACHED DEVICE REMAINED IN THE PATIENT, AND AN UNEXPECTED MEDICAL INTERVENTION WAS REQUIRED. FURTHER DETAILS REGARDING THE INTERVENTION HAVE NOT BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED REQUIRING UNEXPECTED MEDICAL INTERVENTION. A 2.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING CIRCUMFLEX CORONARY ANGIOPLASTY, THE DISTAL BALLOON CATHETER WAS COMPLETELY DETACHED AND MIGRATED INTO THE CORONARY ARTERY. THE DETACHED DEVICE REMAINED IN THE PATIENT, AND AN UNEXPECTED MEDICAL INTERVENTION WAS REQUIRED. FURTHER DETAILS REGARDING THE INTERVENTION HAVE NOT BEEN PROVIDED. IT WAS FURTHER REPORTED THAT THE CORRECT DEVICE SIZE WAS A 2.50MM X 30MM EMERGE BALLOON CATHETER, NOT THE 2.50MM X 15MM NC EMERGE BALLOON CATHETER AS PREVIOUSLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2435193 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493918930250 0035960402 08714729806417

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention