MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number	10371
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	03/08/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that a cranial hemorrhage occurred.A left atrial appendage (laa) closure procedure was performed using a 24mm watchman laa closure device with delivery system (wds).During recovery the patient did not regain consciousness.The patient was transferred to the intensive care unit and cranial imaging was completed.A cranial bleed, attributed to the heparin administered during the index procedure, was identified and the blood drained.
Additional Manufacturer Narrative
A3 sex updated.B2 outcomes attrib to adv event updated.B2 date of death updated.B5 describe event or problem updated.H1 type of reportable event updated.H6 impact code updated.
Event or Problem Description
It was reported that a cranial hemorrhage occurred.A left atrial appendage (laa) closure procedure was performed using a 24mm watchman laa closure device with delivery system (wds).During recovery the patient did not regain consciousness.The patient was transferred to the intensive care unit and cranial imaging was completed.A cranial bleed, attributed to the heparin administered during the index procedure, was identified and the blood drained.It was further reported the patient died prior to discharge after index procedure.

• Brand Name: WATCHMAN LAA CLOSURE DEVICE & DELIVERY 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
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 16590712
• Report Number: 2124215-2023-12160
• Device Sequence Number: 4947975
• Product Code: NGV
• UDI-Device Identifier: 08714729838234
• UDI-Public: 08714729838234
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 11/01/2023

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 Model Number: 10371
• Device Catalogue Number: 10371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Death; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female