MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN TRUSEAL ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number	M635TU70040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	03/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a thrombus occurred.A left atrial appendage (laa) closure procedure was performed using a 24mm watchman laa closure device with delivery system (wds) and a watchman truseal access system (was).Upon implantation, the closure device did not meet pass (position, anchor, size, seal) criteria.The device had a one third to one half mitral shoulder in the 135 degree view.The closure device was recaptured and the was was withdrawn into the right atrium.Transesophageal echocardiogram (tee) revealed a flickering object at the superior portion of the atrial septum near the transseptal puncture in the right atrium.The object was then no longer visible on tee.The procedure was discontinued and the patient was transferred to recovery.In recovery the patient showed no adverse symptoms and was transferred to the post anesthesia care unit.
Event or Problem Description
It was reported that a thrombus occurred.A left atrial appendage (laa) closure procedure was performed using a 24mm watchman laa closure device with delivery system (wds) and a watchman truseal access system (was).Upon implantation, the closure device did not meet pass (position, anchor, size, seal) criteria.The device had a one third to one half mitral shoulder in the 135 degree view.The closure device was recaptured and the was was withdrawn into the right atrium.Transesophageal echocardiogram (tee) revealed a flickering object at the superior portion of the atrial septum near the transseptal puncture in the right atrium.The object was then no longer visible on tee.The procedure was discontinued and the patient was transferred to recovery.In recovery the patient showed no adverse symptoms and was transferred to the post anesthesia care unit.It was further reported that the patient stabilized and was discharged.

• Brand Name: WATCHMAN TRUSEAL ACCESS SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13764735
• Report Number: 2134265-2022-02805
• Device Sequence Number: 3812616
• Product Code: DQY
• UDI-Device Identifier: 08714729965725
• UDI-Public: 08714729965725
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/19/2025
• Device Model Number: M635TU70040
• Device Catalogue Number: M635TU70040
• Device Lot Number: 0028711448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/08/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Race: White