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

Model Number	10373
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Thrombosis (2100)
Date of Event	08/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a thrombus occurred and the patient experienced a cerebral vascular accident.A left atrial appendage (laa) closure procedure was performed.A watchman access system (was) was positioned and a watchman laa closure device & delivery system (wds) were used.The patients activated clotting time (act) was tested as 108 but was considered incorrect.As the act was being retested, the pigtail was advanced over a wire into the was.Upon removal of the wire, a thrombus was visualized by transesophageal echocardiography (tee).The physician performed aspiration on the was and additional heparin was given until act was achieved over 300.The sheath was removed and the groin puncture was held by a non boston scientific 16f sheath over the wire.A new double curve sheath was opened to successfully complete the case.The patient presented neurological deficits upon waking up from the procedure.An immediate ct scan of the head confirmed left middle cerebral artery (mca) stroke.The patient was transferred to intensive care unit and a successful left mca thrombectomy was performed.The patient was cleared by a neurologist to restart their anticoagulation.The patient remained stable and was discharged on (b)(6) 2020.Additionally, the patient was seen on (b)(6) 2020 and weak but speaking.The patient will continue physical therapy assistance at home.

• Brand Name: WATCHMAN ACCESS SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10532911
• Report Number: 2134265-2020-12699
• Device Sequence Number: 1191888
• Product Code: NGV
• UDI-Device Identifier: 08714729838210
• UDI-Public: 08714729838210
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2020

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: 01/08/2023
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0025015476
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 09/14/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR