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	Air Embolism (1697); Thrombosis/Thrombus (4440)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that air was observed and thrombosis occurred.A left atrial appendage (laa) closure procedure was being performed, and a watchman fxd curve access system (was) was selected to be used.During the procedure the physician performed a femoral vein puncture and 5cc of heparin were administrated to the patient.Transeptal puncture was performed and another 3cc of heparin were administrated.The was insertion was made and then the was dilator was removed and flushed.At that time, a thread like thrombus like material was expelled together with bubbles, and its movement was confirmed on echocardiography.It appeared and disappeared only from a single angle, and according to the physician, its appearance differed from that of a typical thrombus, it was not visible from other angles.Gradual disappearance was confirmed on echocardiography.As it had completely disappeared, the procedure was resumed.The procedure was completed.After regaining consciousness from anesthesia, the patient showed no significant changes.There were no adverse events.No further information was provided at the time of this report.
Additional Manufacturer Narrative
With all the available information, boston scientific (bsc) concludes: device technical analysis: the watchman fxd curve? access system was discarded; therefore, returned device analysis could not be completed.Device history record review: a review was completed of the device history records (dhr) for the watchman fxd curve? access system, part # m635tu80010, batch # 0037386684.The device was processed through all normal operational conditions and passed all acceptance activities.The dhr review did not identify any deviations or non-conformances that could have contributed to the event.Labeling review: there was no evidence to suggest that the device was used in a manner inconsistent with the labeling.Watchman fxd curve? access system instructions for use (ifu) lists potential complications, risks and adverse events that may be associated with the use of this device which include air embolism and thrombosis.Risk review: a risk review was completed and confirmed that the events of air embolism and thrombosis were defined in the risk documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.
Event or Problem Description
It was reported that air was observed and thrombosis occurred.A left atrial appendage (laa) closure procedure was being performed, and a watchman fxd curve access system (was) was selected to be used.During the procedure the physician performed a femoral vein puncture and 5cc of heparin were administrated to the patient.Transeptal puncture was performed and another 3cc of heparin were administrated.The was insertion was made and then the was dilator was removed and flushed.At that time, a thread like thrombus like material was expelled together with bubbles, and its movement was confirmed on echocardiography.It appeared and disappeared only from a single angle, and according to the physician, its appearance differed from that of a typical thrombus, it was not visible from other angles.Gradual disappearance was confirmed on echocardiography.As it had completely disappeared, the procedure was resumed.The procedure was completed.After regaining consciousness from anesthesia, the patient showed no significant changes.There were no adverse events.No further information was provided at the time of this report.

• 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: 24649502
• Report Number: 2124215-2026-15474
• Device Sequence Number: 9786396
• Product Code: DQY
• UDI-Device Identifier: 00191506013806
• UDI-Public: (01)00191506013806(17)280904(10)37386684
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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: 0037386684
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/29/2026
• Date Device Manufactured: 09/05/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 97423085-FA
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown