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

Model Number	M635TU80010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was perforation and pericardial effusion.A left atrial appendage (laa) closure procedure was being performed.A watchman fxd curve access system (was) and a watchman flx laa closure device & delivery system (wds) were selected to be used.The physician positioned the was in the laa of the patient and then inserted the wds.The closure device was deployed in the patient, and it appeared to be in the pericardial space with little to no compression.The physician believes that the was perforated the back wall of the laa prior to the wds insertion.A pericardiocentesis was performed to treat the effusion and the patient was given a blood transfusion.The patient was then taken to the operating room where all the devices were removed from the patient and the laa was ligated.The patient is stable following this event and expected to make a full recovery.
Additional Manufacturer Narrative
H6 impact codes: f2302 blood transfusion code added.
Event or Problem Description
It was reported that there was perforation and pericardial effusion.A left atrial appendage (laa) closure procedure was being performed.A watchman fxd curve access system (was) and a watchman flx laa closure device & delivery system (wds) were selected to be used.The physician positioned the was in the laa of the patient and then inserted the wds.The closure device was deployed in the patient, and it appeared to be in the pericardial space with little to no compression.The physician believes that the was perforated the back wall of the laa prior to the wds insertion.A pericardiocentesis was performed to treat the effusion and the patient was given a blood transfusion.The patient was then taken to the operating room where all the devices were removed from the patient and the laa was ligated.The patient is stable following this event and expected to make a full recovery.
Additional Manufacturer Narrative
B5 updated.D4 unique identifier (udi) #: updated.H6 patient codes: e0605 cardiac tamponade code added.
Event or Problem Description
It was reported that there was perforation and pericardial effusion.A left atrial appendage (laa) closure procedure was being performed.A watchman fxd curve access system (was) and a watchman flx laa closure device & delivery system (wds) were selected to be used.The physician positioned the was in the laa of the patient and then inserted the wds.The closure device was deployed in the patient, and it appeared to be in the pericardial space with little to no compression.The physician believes that the was perforated the back wall of the laa prior to the wds insertion.A pericardiocentesis was performed to treat the effusion and the patient was given a blood transfusion.The patient was then taken to the operating room where all the devices were removed from the patient and the laa was ligated.The patient is stable following this event and expected to make a full recovery.It was further reported that the patient experienced a pericardial effusion with cardiac tamponade.

• Brand Name: WATCHMAN FXD CURVE? 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19731334
• Report Number: 2124215-2024-41115
• Device Sequence Number: 8190823
• Product Code: DQY
• UDI-Device Identifier: 00191506013806
• UDI-Public: (01)00191506013806(17)270206(10)33380004
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K212228
• 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,Followup,Followup
• Report Date (Section B): 05/14/2025

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 Model Number: M635TU80010
• Device Catalogue Number: M635TU80010
• Device Lot Number: 0033380004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 07/15/2024; 04/14/2025
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 07/17/2024; 05/14/2025
• Date Device Manufactured: 02/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White