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 Code	Pericardial Effusion (3271)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed, a watchman fxd curve access system (was) and a 20mm watchman flx pro laa closure device & delivery system (wds) were selected to be used.Prior to starting the procedure, a small effusion was noted on the transesophageal echocardiography (tee).As the physician removed the was sheath from the patient's body the effusion was assessed and found to be slightly larger than the start.The 20mm closure device was attempted to be implanted, but the patient's appendage was not suitable for the closure device, so the patient did not receive a closure device.The patient was given protamine and pericardiocentesis was done after the groin closure.A follow-up surface echo was performed prior to discharge and effusion was back to baseline.The patient was discharged home and is fully recovered.
Additional Manufacturer Narrative
H6: impact code added.
Event or Problem Description
It was reported that pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed, a watchman fxd curve access system (was) and a 20mm watchman flx pro laa closure device & delivery system (wds) were selected to be used.Prior to starting the procedure, a small effusion was noted on the transesophageal echocardiography (tee).As the physician removed the was sheath from the patient's body the effusion was assessed and found to be slightly larger than the start.The 20mm closure device was attempted to be implanted, but the patient's appendage was not suitable for the closure device, so the patient did not receive a closure device.The patient was given protamine and pericardiocentesis was done after the groin closure.A follow-up surface echo was performed prior to discharge and effusion was back to baseline.The patient was discharged home and is fully recovered.
Event or Problem Description
It was reported that pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed, a watchman fxd curve access system (was) and a 20mm watchman flx pro laa closure device & delivery system (wds) were selected to be used.Prior to starting the procedure, a small effusion was noted on the transesophageal echocardiography (tee).As the physician removed the was sheath from the patient's body the effusion was assessed and found to be slightly larger than the start.The 20mm closure device was attempted to be implanted, but the patient's appendage was not suitable for the closure device, so the patient did not receive a closure device.The patient was given protamine and pericardiocentesis was done after the groin closure.A follow-up surface echo was performed prior to discharge and effusion was back to baseline.The patient was discharged home and is fully recovered.
Additional Manufacturer Narrative
H6: impact code f2303 medication required removed.H6: impact code f2301 additional device required removed.

• 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: 22286396
• Report Number: 2124215-2025-40320
• Device Sequence Number: 8819894
• Product Code: DQY
• UDI-Device Identifier: 00191506013806
• UDI-Public: (01)00191506013806(17)271105(10)35214744
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/10/2025

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: 0035214744
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 08/27/2025; 09/04/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 08/27/2025; 09/10/2025
• Date Device Manufactured: 11/05/2024
• 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 Sex: Female
• Patient Race: White