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

Model Number M635TU70040

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Date 09/09/2020

Event Type  Injury  

Event Description

It was reported that there was an air embolism.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a watchman laa closure device & delivery system (wds) were selected to be used.While trying to position the was in the laa of the patient a contrast injection was performed to view where the sheath was located.It was then noted on transesophageal echocardiogram and fluoroscopy that there was an air embolism present in the left upper pulmonary vein (lupv).The pigtail catheter was removed from the patient and the was positioned at the lupv entrance.The was slowly advanced while aspirating.The air was aspirated back into the was and could no longer be seen on any of the imaging modalities.There were no st elevations nor any other complications from the air embolism.The procedure was then continued after this, but ultimately a closure device was not implanted in the patient due to the patients anatomy.The patient was doing well following the procedure and there were no other reported complications as a result of this event.

• Brand Name: WATCHMAN TRUSEAL ACCESS SYSTEM
• Type of Device: 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: 10609897
• MDR Text Key: 209338800
• Report Number: 2134265-2020-13031
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729965725
• UDI-Public: 08714729965725
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2023
• Device Model Number: M635TU70040
• Device Catalogue Number: M635TU70040
• Device Lot Number: 0025345013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR