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	Non specific EKG/ECG Changes (1817); Heart Block (4444)
Date of Event	12/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that heart block occurred.A left atrial appendage (laa) closure procedure was performed using a watchman flx laa closure device with delivery system (wds), a watchman fxd curve access system (was), and versacross connect system.Following the removal of the versacross dilator, st elevation was noted and 2:1 heart block occurred.Medication was administered and a temporary pacemaker was placed.A coronary angiogram identified diminished right ventricle function with no evidence of an air embolism.The patient stabilized and cardiac function was restored.The closure device was successfully implanted, and the procedure concluded.During recovery, the patient passed all neurological examinations.No further patient complications were reported.The patient fully recovered and was discharged one day post index procedure.
Additional Manufacturer Narrative
This report is being filed to correct the model number and unique identifier (udi) # in response to an fda request.
Event or Problem Description
It was reported that heart block occurred.A left atrial appendage (laa) closure procedure was performed using a watchman flx laa closure device with delivery system (wds), a watchman fxd curve access system (was), and versacross connect system.Following the removal of the versacross dilator, st elevation was noted and 2:1 heart block occurred.Medication was administered and a temporary pacemaker was placed.A coronary angiogram identified diminished right ventricle function with no evidence of an air embolism.The patient stabilized and cardiac function was restored.The closure device was successfully implanted, and the procedure concluded.During recovery, the patient passed all neurological examinations.No further patient complications were reported.The patient fully recovered and was discharged one day post index procedure.

• 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: 18327143
• Report Number: 2124215-2023-70353
• Device Sequence Number: 7437946
• Product Code: DQY
• UDI-Device Identifier: 00191506013806
• UDI-Public: (01)00191506013806(17)260320(10)31275299
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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: 03/20/2026
• Device Model Number: M635TU80010
• Device Catalogue Number: M635TU80010
• Device Lot Number: 0031275299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2023
• 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
• Patient Age: 78 YR
• Patient Sex: Male