BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FXD CURVE? ACCESS SYSTEM

    MDR report key: 22328076 · Received June 25, 2025

    Report

    Report Number
    2124215-2025-41738
    Event Type
    Injury
    Date Received
    June 25, 2025
    Date of Event
    June 19, 2025
    Report Date
    November 6, 2025
    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
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL MEDIA WAS PROVIDED AND REVIEWED BY A BSC QUALITY ENGINEER. THE PROVIDED MEDICAL MEDIA IS RELATED TO AIR EMBOLISM AND DOES NOT APPEAR TO DEPICT ANY UNRELATED DEVICE OR USER RELATED ALLEGATIONS. NO ADDITIONAL FURTHER REVIEW IS REQUIRED BY BOSTON SCIENTIFIC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AIR EMBOLISM OCCURRED. THE PROCEDURE WAS CANCELLED. A LEFT ATRIAL APPENDAGE CLOSURE (LAA) PROCEDURE WAS BEING PERFORMED. A WATCHMAN FXD CURVE ACCESS SYSTEM (WAS) WAS ADVANCED TO THE LAA. A WATCHMAN CLOSURE DEVICE AND DELIVERY SYSTEM WAS INSERTED, DEPLOYED, BUT DID NOT MEET RELEASE CRITERIA SO IT WAS REMOVED AND THE PROCEDURE WAS ABORTED FOR THIS REASON. WHILE THE WAS AND 16FR NON-BOSTON SCIENTIFIC SHEATH WAS INSIDE THE PATIENT, THE PHYSICIANS USED TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING TO CHECK THE PERICARDIUM FOR EFFUSION. A BRIGHT DENSITY IN THE APEX OF THE LEFT VENTRICLE (LV) WAS OBSERVED. THE PHYSICIAN AND TEAM ATTEMPTED TO SHIFT THE PATIENT BACK AND FORTH TO ATTEMPT TO DISLODGE THE POSSIBLE AIR IN THE LV, YET THE BRIGHT DENSITY WAS STILL PRESENT. THE PATIENT REMAINED STABLE. THE PATIENT WAS EXTUBATED, WOKE UP AND WAS ALERT AND RESPONDING TO QUESTIONS. THE PATIENT STAYED OVERNIGHT FOR OBSERVATION AND WAS THEN DISCHARGED TO HOME WITHOUT ANY ADDITIONAL INTERVENTIONS TAKING PLACE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AIR EMBOLISM OCCURRED. THE PROCEDURE WAS CANCELLED. A LEFT ATRIAL APPENDAGE CLOSURE (LAA) PROCEDURE WAS BEING PERFORMED. A WATCHMAN FXD CURVE ACCESS SYSTEM (WAS) WAS ADVANCED TO THE LAA. A WATCHMAN CLOSURE DEVICE AND DELIVERY SYSTEM WAS INSERTED, DEPLOYED, BUT DID NOT MEET RELEASE CRITERIA SO IT WAS REMOVED AND THE PROCEDURE WAS ABORTED FOR THIS REASON. WHILE THE WAS AND 16FR NON-BOSTON SCIENTIFIC SHEATH WAS INSIDE THE PATIENT, THE PHYSICIANS USED TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING TO CHECK THE PERICARDIUM FOR EFFUSION. A BRIGHT DENSITY IN THE APEX OF THE LEFT VENTRICLE (LV) WAS OBSERVED. THE PHYSICIAN AND TEAM ATTEMPTED TO SHIFT THE PATIENT BACK AND FORTH TO ATTEMPT TO DISLODGE THE POSSIBLE AIR IN THE LV, YET THE BRIGHT DENSITY WAS STILL PRESENT. THE PATIENT REMAINED STABLE. THE PATIENT WAS EXTUBATED, WOKE UP AND WAS ALERT AND RESPONDING TO QUESTIONS. THE PATIENT STAYED OVERNIGHT FOR OBSERVATION AND WAS THEN DISCHARGED TO HOME WITHOUT ANY ADDITIONAL INTERVENTIONS TAKING PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367765 WATCHMAN FXD CURVE? ACCESS SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL DQY BOSTON SCIENTIFIC CORPORATION M635TU80020 0036192191 00191506013813

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Hospitalization| O