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 Codes	Chest Pain (1776); Dyspnea (1816); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a cardiac perforation and pericardial effusion occurred.A left atrial appendage (laa) closure procedure was performed using a 27mm watchman flx laa closure device with delivery system (wds) and watchman truseal access system (was).It was reported the patient had no pericardium due to previous cardiothoracic surgeries and a pericardial effusion was noted prior to the procedure.The closure device was partially deployed outside of the heart before being positioned in the laa.A peri device jet was observed and the closure device was recaptured and removed from the patient.After removal of the first closure device the was sheath perforated the wall of the laa.A second 27mm closure device was implanted and the procedure was completed.Once the patient was in recovery, heparin was reversed.The patient reported chest pain, discomfort, and shortness of breath.The patient was discharged and will be monitored in an outpatient clinic.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14915507
• Report Number: 2124215-2022-23481
• Device Sequence Number: 19340761
• Product Code: DQY
• UDI-Device Identifier: 08714729965725
• UDI-Public: 08714729965725
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 07/05/2022

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: 03/31/2025
• Device Model Number: M635TU70040
• Device Catalogue Number: M635TU70040
• Device Lot Number: 0029150344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• 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: 82 YR
• Patient Sex: Female
• Patient Race: White