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

Model Number	10373
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	04/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a thrombus occurred.A left atrial appendage (laa) closure procedure was being performed.The activated clotting time (act) was in the range of 200 to 300 seconds and the patient was on warfarin and stopped taking this two days prior to the procedure.The implanting team initially had difficulty engaging the septum and upon crossing of the septum, the team had difficulty exchanging to a double curve watchman access system (was) as the septum was reported to be tough.After repeated attempts with the dilator, the septum was successfully crossed.Upon removal of the non-boston scientific wire, thrombus was identified via echocardiography on the septum at the septal crossing in the right atrium and on the tip of the was.The thrombus was reported to be mobile.An attempt was made to aspirate the thrombus, however, this was unsuccessful.The was pulled back into the right atrium and out of the body.Once removed from the body, an organized thrombus was identified on the outer sheath of the was.The procedure was aborted and the patient was extubated.There were no cognitive defects and the patient was neurologically intact.The patient was discharged home the same day as the aborted procedure.

• 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: 11822770
• Report Number: 2134265-2021-05408
• Device Sequence Number: 13718398
• Product Code: NGV
• UDI-Device Identifier: 08714729838203
• UDI-Public: 08714729838203
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2021

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: 09/15/2023
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0026017033
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR