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

Model Number	M635TU80010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Air Embolism (1697); Cardiac Arrest (1762)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via medwatch that there was an air embolus, and the patient went into cardiac arrest.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 inserted the was into the patient and positioned it into the laa.At this time, it was noted that there was an air embolism in the patient.The patient went into cardiac arrest and needed to be resuscitated.The patient recovered and was transferred to the intensive care unit to recover from this event.Medwatch #: (b)(4).
Event or Problem Description
It was reported via medwatch that there was an air embolus, and the patient went into cardiac arrest.A left atrial appendage (laa) closure procedure was being performed.A watchman fxd curve access system (was) and a watchman flx laa closure device and delivery system (wds) were selected to be used.The physician inserted the was into the patient and positioned it into the laa.At this time, it was noted that there was an air embolism in the patient.The patient went into cardiac arrest and needed to be resuscitated.The patient recovered and was transferred to the intensive care unit to recover from this event.Medwatch# mw5146669.
Additional Manufacturer Narrative
This report is being filed to correct the model number and unique identifier (udi) # in response to an fda request.

• 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: 18065061
• Report Number: 2124215-2023-60687
• Device Sequence Number: 7573071
• Product Code: DQY
• UDI-Device Identifier: 00191506013806
• UDI-Public: (01)00191506013806(17)250816(10)29970350
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024

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: 08/16/2025
• Device Model Number: M635TU80010
• Device Catalogue Number: M635TU80010
• Device Lot Number: 0029970350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 07/03/2024
• 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 Sex: Unknown