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 Code	Air Embolism (1697)
Date of Event	10/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was air seen in the device and the patient.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned.A 30mm watchman laa closure device & delivery system (wds) was advanced.The closure device was deployed in the laa, but was too proximal and needed to be fully recaptured.A new wds was opened and inserted into the was.As the device was being advanced air was visually seen inside the was.The physician was able to aspirate the air and pulled the device back out.They re-flushed prior to introducing again.It was noted that there may have been a trace amount of air in the appendage and they were able to aspirate it through the was.The patient had no adverse event.The procedure was continued and they were able to deploy the closure device in the laa successfully.There were no other complications that were reported.The patient was reported to be fine and 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: 9241862
• Report Number: 2134265-2019-12840
• Device Sequence Number: 1611475
• Product Code: NGV
• UDI-Device Identifier: 08714729838210
• UDI-Public: 08714729838210
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/25/2019

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: 01/23/2022
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0023236272
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 10/25/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR