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 Code	Thrombosis (2100)
Date of Event	02/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a thrombus occurred.A watchman access system (was) single curve and 27mm watchman laa closure device & delivery system (wds) were selected for use during a left atrial appendage (laa) closure procedure.Before the start of the procedure, a baseline pericardial effusion was noted.Prior to crossing the septum, a thrombus was visualized in the right atrium.No interventions were performed for the thrombus; however, the physician gave heparin after the septum was crossed.The procedure continued and the closure device was successfully implanted.Approximately, two hours post-procedure, the patient became hypotensive and experienced chest pain.A cardiac tamponade was discovered and a pericardiocentesis was performed to remove 500 cc of fluid from the pericardial space.The drain was removed and the patient was stable.

• 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: 8418176
• Report Number: 2134265-2019-02276
• Device Sequence Number: 16463247
• Product Code: NGV
• UDI-Device Identifier: 08714729838197
• UDI-Public: 08714729838197
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/13/2019

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: 11/02/2021
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 22885182
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 03/13/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other