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

Model Number	10373
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059)
Date of Event	01/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was air in the device.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 24mm watchman laa closure device & delivery system (wds) were used.The was was positioned in the laa of the patient and the wds was inserted into the access sheath.When the device was inserted, air entered into the was.The air was visualized on transesophageal echocardiogram and monitored until it resolved.During this time the patient had a transient st segment elevation and became hypotensive.These were medically managed and the patient returned to normal within 10minutes.After the patient stabilized, the procedure was continued.The closure device was deployed and successfully implanted in the laa of the patient.There were no patient deficits or issues that occurred post procedure.The patient was doing fine.

• 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: 9661356
• Report Number: 2134265-2020-00682
• Device Sequence Number: 3655200
• Product Code: NGV
• UDI-Device Identifier: 08714729838197
• UDI-Public: 08714729838197
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2020

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: 10/13/2022
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0024594066
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 02/03/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention