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

Model Number	M635TU70010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Non specific EKG/ECG Changes (1817); Transient Ischemic Attack (2109)
Date of Event	06/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that st elevation and a suspected transient ischemic attack (tia) occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman truseal access system (was) was positioned and a 24mm watchman flx laa closure device & delivery system (wds) were used.During manipulation of the was sheath, st elevation was noted.An air embolism was suspected but air was never visualized in the device or patient.The patient was placed on oxygen.The closure device was successfully implanted.Post procedure, the patient had tia symptoms but a tia was only suspected by the implanting physician.The computed tomography (ct) scan findings were normal.The arm and leg weakness the patient experienced was resolving.No additional information is known at this time.

• 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
• MDR Report Key: 12158863
• Report Number: 2134265-2021-08852
• Device Sequence Number: 14633541
• Product Code: DQY
• UDI-Device Identifier: 08714729965701
• UDI-Public: 08714729965701
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2021

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: 02/11/2024
• Device Model Number: M635TU70010
• Device Catalogue Number: M635TU70010
• Device Lot Number: 0026794159
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other