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	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	04/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a perforation with pericardial effusion.A left atrial appendage (laa) closure procedure was being performed.A watchman truseal access system (was) was positioned and a watchman flx laa closure device & delivery system (wds) were used.The physician positioned the was in the laa of the patient and then began to insert the wds.While inserting the wds the physician felt the was move and perforate the laa of the patient.The perforation resulted in a pericardial effusion.The physician performed a pericardiocentesis to tap and drain the fluid from the effusion.The effusion was treated and the procedure was continued.The procedure was completed successfully with the closure device implanted in the laa of the patient.The effusion was monitored for two hours post procedure and the patient remained in the hospital for 24 hours to be monitored.There were no other interventions or treatments that were performed for the patient.The patient is expected to make a full recovery from these events.

• 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: 14196518
• Report Number: 2134265-2022-04640
• Device Sequence Number: 4406427
• Product Code: DQY
• UDI-Device Identifier: 08714729965725
• UDI-Public: 08714729965725
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/25/2022

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: 01/10/2025
• Device Model Number: M635TU70040
• Device Catalogue Number: M635TU70040
• Device Lot Number: 0028657962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Race: White