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 Arrest (1762); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	07/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a pericardial effusion occurred.A left atrial appendage closure (laac) procedure was being performed.The physician was attempting to perform the transeptal puncture (tsp) with a non-boston scientific (bsc) brk needle and non-bsc sro sheath.The physician fellow was attempting tsp and was having trouble visualizing where the tip of the sheath/dilator was on the septum.At this point, the implanting physician took over and could see on echocardiography that tsp device was on the septum, but not on the fossa ovalis and was anterior.The non-bsc brk needle was then advance through the septum.The echo imager and the bsc rep verbalized that they were unsure that this was a safe or optimal position for tsp.The physician continued to advance the non-bsc sro sheath forward.The physician removed the non-bsc brk needle, advanced an amplatz super stiff wire that went outside the cardiac silhouette, and advanced the watchman fxd curve access system (was) sheath over the amplatz super stiff wire without confirming with the echo physician that it was in a vein.The implanting physician asked for an effusion check at this time.There was a growing pericardial effusion noted.The staff prepared for pericardiocentesis, and 800ml was pulled from the pericardium.The patient began to stabilize.The physician was adamant that this patient needed a watchman closure device due to the electrically isolated laa.The anesthesiologist gave heparin, and the physician went forward with the procedure.The patient was noted to have challenging anatomy.The physician attempted to go in with a watchman closure device when the imager noticed that the pericardial effusion was growing.The patient became unstable and cardiopulmonary resuscitation (cpr) was performed.The cardiothoracic (ct) surgeon was called and performed open heart surgery to repair the perforation and treat the effusion.During surgery the laa was ligated.Ecmo was initiated, and the patient became hemodynamically stable as the surgery was completed.The patient remains in the hospital for recovery and was reported to be doing well.

• 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: 19827161
• Report Number: 2124215-2024-45826
• Device Sequence Number: 8684727
• Product Code: DQY
• UDI-Device Identifier: 00191506013806
• UDI-Public: 00191506013806
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/25/2024

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: 08/14/2026
• Device Model Number: TU-8001
• Device Catalogue Number: TU-8001
• Device Lot Number: 0032222593
• 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: 07/18/2024
• Initial Report FDA Received Date: 07/25/2024
• Date Device Manufactured: 08/15/2023
• 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; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Race: White