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

Model Number	M635TU70020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a thrombus present.A left atrial appendage (laa) closure procedure was being performed.A watchman truseal access system (was) and a 31mm watchman flx laa closure device & delivery system (wds) were selected to be used.The physician successfully performed the transseptal puncture and then inserted the was.The was positioned in the laa of the patient and an angiogram was then performed.The angiogram showed that there was a dense echo contrast that was along the coumadin ridge at the ostium of the laa.The physician believed that this was a thrombus that was present in the patient.The decision was made to continue with the procedure.The closure device was successfully implanted in the laa of the patient.There were no consequences as a result of this event.The patient is doing fine post procedure.

• Brand Name: WATCHMAN TRUSEAL ACCESS SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17079855
• Report Number: 2124215-2023-28847
• Device Sequence Number: 2249971
• Product Code: DQY
• UDI-Device Identifier: 08714729965718
• UDI-Public: 08714729965718
• 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
• Report Date (Section B): 06/07/2023

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: 02/20/2025
• Device Model Number: M635TU70020
• Device Catalogue Number: M635TU70020
• Device Lot Number: 0028907198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• 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