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

Model Number	M635TU70010
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	01/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was air in the device and an air embolism occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a watchman flx laa closure device & delivery system (wds) were used.The physician positioned the was in the laa of the patient.The pigtail catheter was taken out of the patient and the wds was then inserted into the was.While inserting the wds air was seen in the was which then was pushed out into the laa of the patient.The physician attempted to aspirate the air embolism, but it moved to the left ventricle.200mcg of nitro and 100% fio2 was given to the patient to treat the air embolism.After this treatment the air resolved and the procedure was continued.The physician completed the procedure successfully with the closure device being implanted in the laa of the patient.There were no other complications that occurred during the procedure.2 hours post procedure the physician was imaging the closure device and laa of the patient when it was noted that there was a pericardial effusion in the left ventricle.The patient had some chest pain and there was a small fluid collection.No intervention was performed for the effusion, the patient was continuously monitored.The patient is expected to make a full recovery from these events.

• Brand Name: WATCHMAN TRUSEAL ACCESS SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13508366
• Report Number: 2134265-2022-01314
• Device Sequence Number: 5038757
• Product Code: DQY
• UDI-Device Identifier: 08714729965701
• UDI-Public: 08714729965701
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2022

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: 07/13/2023
• Device Model Number: M635TU70010
• Device Catalogue Number: M635TU70010
• Device Lot Number: 0025702998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Race: White