MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN FXD Curve? Access System; system, appendage closure, left atrial

Model Number	M635TU80020
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was air within the sheath.A left atrial appendage closure (laac) procedure was being performed.A watchman fxd curve access system (was) and a 27mm watchman closure device and delivery system (wds) were selected for use.The was was introduced into the left atrium using a pigtail wire.The physician set up for a contrast shot.Prior to injecting the contrast, the physician stepped on fluoroscopy.An 8mm bubble was noted in the was.The physician aspirated the was and pulled back the air.The patient was stable for the remainder of the procedure.The physician reports the patient was doing well and planned to discharge the patient the next day.
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 # m635tu80020 batch # 0039379559.The dhr review confirmed that the device met all material, assembly, and performance specifications prior to distribution.Labeling review: there was no evidence to suggest that the device was used in a manner inconsistent with the labeling.Risk review: a risk review was completed and confirmed that the events of access system - entrapped air was defined in the risk documentation.This event type has 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 adverse event related to procedure.

• 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; multitenant #2, street #58 zon; cartago, 03 30106 ; EI 30106
• Manufacturer Contact: mary crawford ; 4100 hamline ave n; arden hills, MN 55112 ; +1(651)440-0979
• MDR Report Key: 25892702
• Report Number: 2124215-2026-39105
• Device Sequence Number: 13250946
• Product Code: DQY
• UDI-Device Identifier: 00191506013813
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K212228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M635TU80020
• Device Catalogue Number: M635TU80020
• Device Lot Number: 0039379559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Supplement Date Received by Manufacturer: 07/16/2026; 09/18/2026
• Initial Report FDA Received Date: 07/21/2026
• Supplement Report FDA Received Date: 07/27/2026; 09/22/2026
• Date Device Manufactured: 05/19/2026
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 213 LB