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

Model Number	TU-8001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	01/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that perforation and pericardial effusion (pe) occurred.A left atrial appendage (laa) closure procedure was being performed.The patient's laa anatomy was posterior and inferior with chicken wing configuration.Trans-septal puncture was performed mid-posterior.Transesophageal echocardiogram (tee) and computed tomography (ct) measurements suggested sizing for a 24mm watchman flx closure device and delivery system (wds).A watchman fxd access system (was) was positioned and a 24mm wds was prepared and inserted.Over five deployments and partial recaptures were performed before removal of the 24mm wds.A 20mm wds was then prepared and inserted.The 20mm wds reached a more optimal position than the previous 24mm wds, however it did not meet position, anchor, size, seal (pass) criteria and was therefore removed.The was repositioned and a new 24mm wds was prepared and inserted.As the 24mm wds was being inserted, the was aggressively spun out of the desired location and the decision was made to abort the procedure.Echocardiogram then revealed a large pe.An emergent pericardiocentesis was performed and the patient was transferred to the operating room for surgery.A 3mm perforation was located at the apex of the laa and surgical ligation of the laa was successfully performed.The patient remains in recovery with expected discharge within the week.

• Brand Name: WATCHMAN FXD CURVE ACCESS SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16134038
• Report Number: 2124215-2023-00628
• Device Sequence Number: 14265838
• Product Code: DQY
• UDI-Device Identifier: 00191506013806
• UDI-Public: 00191506013806
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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
• Report Date (Section B): 01/10/2023

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 Expiration Date: 08/16/2025
• Device Model Number: TU-8001
• Device Catalogue Number: TU-8001
• Device Lot Number: 0029971506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Race: White