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); Respiratory Arrest (4461)
Date of Event	06/06/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died.A left atrial appendage (laa) closure procedure was being performed.A watchman fxd curve access system (was) and a watchman flx laa closure device & delivery system (wds) were selected to be used.The physician positioned in the was in the laa of the patient and then inserted the ice catheter and was.The physician manipulated the was due to the ease of aspiration they noted.The physician then removed the was catheter and reflushed the device before reinserting it back into the patient.At this moment.The patient had a large audible gasp and the anesthesiologist noted that the patient was not breathing.The patient was intubated, and cardiopulmonary resuscitation (cpr) was started.Cpr was performed for ten (10) minutes, but the patient's pulse nor respiration returned.The patient did not recover, and the patient died due to the respiratory arrest.

• 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: 19532086
• Report Number: 2124215-2024-35270
• Device Sequence Number: 7501769
• Product Code: DQY
• UDI-Device Identifier: 00191506013806
• UDI-Public: 00191506013806
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 06/13/2024

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 Model Number: TU-8001
• Device Catalogue Number: TU-8001
• Device Lot Number: 0033526480
• 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: 06/06/2024
• Initial Report FDA Received Date: 06/13/2024
• Date Device Manufactured: 02/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 81 YR
• Patient Sex: Male