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	Pericardial Effusion (3271)
Date of Event	07/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pericardial effusion (pe) occurred.A left atrial appendage (laa) closure procedure was being performed.Trans-septal puncture (tsp) was performed and a watchman truseal access system (was) was inserted.After crossing the septum with the was, a pigtail catheter was inserted and the was manipulated.A pe was noted on the left side of the heart via transesophageal echocardiogram (tee).It is unknown if the tsp or the was caused the pe.A pericardiocentesis was performed and 900cc of fluid was removed.The patient is stable and staying overnight in the hospital.The patient is expected to re-attempt laa closure at a future date.

• 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: 15179960
• Report Number: 2124215-2022-29077
• Device Sequence Number: 6302135
• 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): 08/05/2022

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: 05/11/2025
• Device Model Number: M635TU70020
• Device Catalogue Number: M635TU70020
• Device Lot Number: 0029387754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• 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: 78 YR
• Patient Sex: Male
• Patient Race: White