BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FXD CURVE? ACCESS SYSTEM

    MDR report key: 24070311 · Received January 14, 2026

    Report

    Report Number
    2124215-2026-02525
    Event Type
    Injury
    Date Received
    January 14, 2026
    Date of Event
    January 6, 2026
    Report Date
    March 11, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    UDI-DI
    00191506013813
    PMA / PMN Number
    K212228
    Removal / Correction Number
    97423085-FA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC (BSC) CONCLUDES: DEVICE TECHNICAL ANALYSIS. THE WATCHMAN FXD CURVE? ACCESS SYSTEM WAS DISCARDED; THEREFORE, RETURNED DEVICE .ANALYSIS COULD NOT BE COMPLETED. MEDIA REVIEW. PROCEDURAL MEDIA WAS PROVIDED TO AID IN THE INVESTIGATION AND WAS REVIEWED BY A BSC MEDICAL SAFETY REPRESENTATIVE. THE PROVIDED MEDICAL MEDIA IS RELATED TO AIR EMBOLISM AND DOES NOT APPEAR TO DEPICT ANY UNRELATED DEVICE OR USER RELATED ALLEGATIONS. DEVICE HISTORY RECORD REVIEW. A REVIEW WAS COMPLETED OF THE DEVICE HISTORY RECORDS (DHR) FOR THE WATCHMAN FXD CURVE? ACCESS SYSTEM, PART # M635TU80020 BATCH # 0037598672. THE DEVICE WAS PROCESSED THROUGH ALL NORMAL OPERATIONAL CONDITIONS AND PASSED ALL ACCEPTANCE ACTIVITIES. THE DHR REVIEW DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE EVENT. LABELING REVIEW. THERE WAS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELING. WATCHMAN FXD CURVE? ACCESS SYSTEM INSTRUCTIONS FOR USE (IFU) LISTS POTENTIAL COMPLICATIONS, RISKS AND ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THIS DEVICE WHICH INCLUDE AIR EMBOLISM (ST SEGMENT ELEVATION, LOW CARDIAC OUTPUT) (UNEXPECTED DIAGNOSTIC INTERVENTION). RISK REVIEW. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF AIR EMBOLISM (ST SEGMENT ELEVATION, LOW CARDIAC OUTPUT) 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. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AIR EMBOLISM AND ST SEGMENT CHANGES OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED UNDER GENERAL ANESTHESIA USING TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), INTRACARDIAC ECHOCARDIOGRAM (ICE) IMAGING, AND FLUOROSCOPY IMAGING. A WATCHMAN FXD CURVE ACCESS SYSTEM WAS INSERTED, AND IT WAS EXCHANGED FOR A WATCHMAN FXD DOUBLE CURVE ACCESS SYSTEM (WAS). A 24MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED WITHOUT DIFFICULTY. FOLLOWING DEVICE DEPLOYMENT, AIR WAS IDENTIFIED WITHIN THE LEFT VENTRICLE, SEEN ON TEE. AT THIS TIME, THE WAS AND CLOSURE DEVICE WERE IN THE HEART, AND THE ICE CATHETER WAS ON THE RIGHT SIDE OF THE HEART. THE PATIENT DEMONSTRATED ST SEGMENT CHANGES AND TRANSIENT DECREASED LEFT VENTRICULAR FUNCTION. AN INTERVENTIONAL CARDIOLOGIST PERFORMED A CARDIAC CATHETERIZATION, WHICH DID NOT IDENTIFY FINDINGS REQUIRING FURTHER INTERVENTION. THE AIR EMBOLISM RESOLVED, AND THE PATIENT WAS MONITORED OVERNIGHT. THE PATIENT IS EXPECTED TO FULLY RECOVER AND THEN WAS DISCHARGED THE FOLLOWING DAY. THE SOURCE OF AIR ENTRY COULD NOT BE DEFINITIVELY DETERMINED, THOUGH IT WAS SUSPECTED TO HAVE OCCURRED DURING WAS SHEATH EXCHANGES OR VIA THE ICE ACCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AIR EMBOLISM AND ST SEGMENT CHANGES OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED UNDER GENERAL ANESTHESIA USING TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), INTRACARDIAC ECHOCARDIOGRAM (ICE) IMAGING, AND FLUOROSCOPY IMAGING. A WATCHMAN FXD CURVE ACCESS SYSTEM WAS INSERTED, AND IT WAS EXCHANGED FOR A WATCHMAN FXD DOUBLE CURVE ACCESS SYSTEM (WAS). A 24MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED WITHOUT DIFFICULTY. FOLLOWING DEVICE DEPLOYMENT, AIR WAS IDENTIFIED WITHIN THE LEFT VENTRICLE, SEEN ON TEE. AT THIS TIME, THE WAS AND CLOSURE DEVICE WERE IN THE HEART, AND THE ICE CATHETER WAS ON THE RIGHT SIDE OF THE HEART. THE PATIENT DEMONSTRATED ST SEGMENT CHANGES AND TRANSIENT DECREASED LEFT VENTRICULAR FUNCTION. AN INTERVENTIONAL CARDIOLOGIST PERFORMED A CARDIAC CATHETERIZATION, WHICH DID NOT IDENTIFY FINDINGS REQUIRING FURTHER INTERVENTION. THE AIR EMBOLISM RESOLVED, AND THE PATIENT WAS MONITORED OVERNIGHT. THE PATIENT IS EXPECTED TO FULLY RECOVER AND THEN WAS DISCHARGED THE FOLLOWING DAY. THE SOURCE OF AIR ENTRY COULD NOT BE DEFINITIVELY DETERMINED, THOUGH IT WAS SUSPECTED TO HAVE OCCURRED DURING WAS SHEATH EXCHANGES OR VIA THE ICE ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465993 WATCHMAN FXD CURVE? ACCESS SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL DQY BOSTON SCIENTIFIC CORPORATION M635TU80020 0037598672 00191506013813

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Other