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 Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a pericardial effusion.Prior to the start of the procedure it was noted that the patient had a 1.3cm sized pericardial effusion.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 20mm watchman flx laa closure device & delivery system (wds) were used.The procedure was completed successfully with the closure device implanted in the laa of the patient.During the procedure the patients blood pressure had dropped so the physician wanted to perform a pericardiocentesis post procedure.It was also noted that the right sided pericardial effusion had a slight increase in size.The physician performed a pericardiocentesis and drained 300 to 500cc of fluid from the patient.Following this treatment the effusion was resolved.The patient made a full recovery and was discharged the next day as planned.

• 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: 15105811
• Report Number: 2124215-2022-26622
• Device Sequence Number: 14490551
• Product Code: DQY
• UDI-Device Identifier: 08714729965718
• UDI-Public: 08714729965718
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/26/2022

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: 03/30/2025
• Device Model Number: M635TU70020
• Device Catalogue Number: M635TU70020
• Device Lot Number: 0029141797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• 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: 85 YR
• Patient Sex: Female