BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN TRUSTEER? ACCESS SYSTEM

    MDR report key: 23898104 · Received December 26, 2025

    Report

    Report Number
    2124215-2025-93164
    Event Type
    Injury
    Date Received
    December 26, 2025
    Date of Event
    December 12, 2025
    Report Date
    March 18, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    UDI-DI
    00191506022310
    PMA / PMN Number
    K240018
    Removal / Correction Number
    97423085-FA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 TRUSTEER? 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 QUALITY ENGINEER. 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 TRUSTEER? ACCESS SYSTEM, PART # M635TU90050 BATCH # 0037692402. 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 TRUSTEER? 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 (ADDITIONAL DEVICE REQUIRED). RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF AIR EMBOLISM 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 OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED, AND A WATCHMAN TRUSTEER ACCESS SYSTEM (WAS) WAS SELECTED TO BE USED. DURING THE PROCEDURE, ONCE THE TRANSEPTAL SHEATH WAS IN PLACE, THE PIGTAIL CATHETER WAS PLACED IN THE LEFT ATRIUM AND A PRESSURE OF 6MMHG WAS RECORDED. SUBSEQUENTLY WHEN THE PHYSICIAN PROCEEDED TO EXCHANGE THE PIGTAIL CATHETER FOR THE DELIVERY SYSTEM, THERE WAS NO BLEED BACK FROM THE WAS SHEATH. THE PHYSICIAN LOWERED THE TIP OF THE WAS SHEATH BELOW THE MIDAXILLARY LINE, AT WHICH POINT THERE WAS POSITIVE BLEED BACK AND WERE ABLE TO PERFORM A WET-TO-WET CONNECTION. THE REST OF THE PROCEDURE WENT FINE. THE DEPLOYMENT WAS SUCCESSFUL, BUT AIR WAS NOTICED IN THE LEFT VENTRICLE POST DEPLOYMENT. THE PHYSICIAN ADVANCED THE PIGTAIL CATHETER INTO THE LEFT VENTRICLE TO ASPIRATE MANUALLY, AND THE PATIENT WAS KEPT ON THE TABLE INTUBATED TO ALLOW THE AIR EMBOLISM TO DISSIPATE. THE PATIENT WAS DISCHARGED THE SAME DAY AND IS EXPECTED TO FULLY RECOVER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AIR EMBOLISM OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED, AND A WATCHMAN TRUSTEER ACCESS SYSTEM (WAS) WAS SELECTED TO BE USED. DURING THE PROCEDURE, ONCE THE TRANSEPTAL SHEATH WAS IN PLACE, THE PIGTAIL CATHETER WAS PLACED IN THE LEFT ATRIUM AND A PRESSURE OF 6MMHG WAS RECORDED. SUBSEQUENTLY WHEN THE PHYSICIAN PROCEEDED TO EXCHANGE THE PIGTAIL CATHETER FOR THE DELIVERY SYSTEM, THERE WAS NO BLEED BACK FROM THE WAS SHEATH. THE PHYSICIAN LOWERED THE TIP OF THE WAS SHEATH BELOW THE MIDAXILLARY LINE, AT WHICH POINT THERE WAS POSITIVE BLEED BACK AND WERE ABLE TO PERFORM A WET-TO-WET CONNECTION. THE REST OF THE PROCEDURE WENT FINE. THE DEPLOYMENT WAS SUCCESSFUL, BUT AIR WAS NOTICED IN THE LEFT VENTRICLE POST DEPLOYMENT. THE PHYSICIAN ADVANCED THE PIGTAIL CATHETER INTO THE LEFT VENTRICLE TO ASPIRATE MANUALLY, AND THE PATIENT WAS KEPT ON THE TABLE INTUBATED TO ALLOW THE AIR EMBOLISM TO DISSIPATE. THE PATIENT WAS DISCHARGED THE SAME DAY AND IS EXPECTED TO FULLY RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581326 WATCHMAN TRUSTEER? ACCESS SYSTEM CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION M635TU90050 0037692402 00191506022310

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention