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

Model Number	M635TU80020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pericardial effusion occurred.A left atrial appendage closure (laac) procedure was being performed.A watchman fxd curve access system (was) and a 24 mm watchman flx pro laa closure device and delivery system (wds) were selected for use.Intracardiac echo (ice) imaging was used initially but was difficult to see due to the patient anatomy.The remainder of the case was completed under transesophageal echocardiography (tee) guidance.Pre-imaging was completed to see the size and morphology of the appendage as well as to scan for an effusion.There was no trace effusion noted.Access was obtained in the right femoral vein.A standard j-wire was inserted in the inferior vena cava (ivc) to the superior vena cava (sva), followed by the double curve sheath and the versacross connect.The j-wire was removed and replaced with rf wire.The physician used tee for proper positioning for the transeptal puncture (tsp).Due to the anatomy of the patient, the tsp was limited on where it could cross the septum.After the tsp, the rf wire was advanced into the la, where it did fall into the mitral valve multiple times.The physician did have difficulty attempting to advance the double curve sheath with the versacross connect dilator.The double curve was then advanced without the versacross dilator in the sheath and went through the septum.Tee showed a growing pericardial effusion, which measured 1.03 cm.The physician was made aware of the effusion and continued with the procedure.The wds was placed and met all position, anchor, size and seal (pass) criteria.After the device was released, the physician followed up on the effusion and noted it had grown to 1.62 cm.Pericardiocentesis was attempted, but no fluid was able to be tapped.The physician discontinued the tap and referred back to tee, where an effusion could no longer be seen.The patient was extubated and sent to recovery with the intention to follow up with another tee two hours later.There were no additional concerns reported.
Event or Problem Description
It was reported that pericardial effusion occurred.A left atrial appendage closure (laac) procedure was being performed.A watchman fxd curve access system (was) and a 24mm watchman flx pro laa closure device and delivery system (wds) were selected for use.Intracardiac echo (ice) imaging was used initially, but was difficult to see due to the patient anatomy.The remainder of the case was completed under transesophageal echocardiography (tee) guidance.Pre-imaging was completed to see the size and morphology of the appendage as well as to scan for an effusion.There was no trace effusion noted.Access was obtained in the right femoral vein.A standard j-wire was inserted in the inferior vena cava (ivc) to the superior vena cava (sva), followed by the double curve sheath and the versacross connect.The j-wire was removed and replaced with rf wire.The physician used tee for proper positioning for the transeptal puncture (tsp).Due to the anatomy of the patient, the tsp was limited on where it could cross the septum.After the tsp the rf wire was advanced into the la, where it did fall into the mitral valve multiple times.The physician did have difficulty attempting to advance the double curve sheath with the versacross connect dilator.The double curve was then advanced without the versacross dilator in the sheath and went through the septum.Tee showed a growing pericardial effusion, which measured 1.03cm.The physician was made aware of the effusion and continued with the procedure.The wds was placed and met all position, anchor, size and seal (pass) criteria.After the device was released, the physician followed up on the effusion and noted it had grown to 1.62cm.Pericardiocentesis was attempted, but no fluid was able to be tapped.The physician discontinued the tap and referred back to tee, where an effusion could no longer be seen.The patient was extubated and sent to recovery with the intention to follow up with another tee two hours later.There were no additional concerns reported.It was further reported there were no concerns on the follow up tee.The patient has been discharged on a post procedure regimen of aspirin and plavix.
Additional Manufacturer Narrative
B5 describe event or problem - updated with gfe information.

• 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 ; CS 30106
• Manufacturer Contact: mary crawford ; 4100 hamline ave n; arden hills, MN 55112 ; +1(651)440-0979
• MDR Report Key: 25847635
• Report Number: 2124215-2026-38346
• Device Sequence Number: 10435326
• Product Code: DQY
• UDI-Device Identifier: 00191506013813
• UDI-Public: (01)00191506013813(17)290119(10)38390841
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 09/24/2026

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: M635TU80020
• Device Catalogue Number: M635TU80020
• Device Lot Number: 0038390841
• 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: 07/10/2026
• Supplement Date Received by Manufacturer: 07/16/2026; 07/10/2026; 09/24/2026
• Initial Report FDA Received Date: 07/16/2026
• Supplement Report FDA Received Date: 07/20/2026; 07/27/2026; 09/24/2026
• Date Device Manufactured: 01/20/2026
• 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: Female