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

Model Number M635TU70020

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

Patient Problem Air Embolism (1697)

Event Date 06/22/2021

Event Type  Injury  

Event Description

It was reported an air embolism occurred.A left atrial appendage (laa) closure procedure was being performed.A double curve truseal watchman access system (was) was positioned and a 31mm watchman flx laa closure device & delivery system (wds) were used.During the case after the left atrial (la) pressure was measured, the physician decided to give the patient a few cc's of heparinized saline into the side arm of the was sheath from a manifold.Approximately 30 cc's of fluid was given, the blue valve was closed and blood was pulled back prior to pushing anything forward to check for air.There was no imaging being done during this time.The device was prepped as normal and checked for air.A wet to wet connection was performed and the device was successfully deployed.It was after this that air was noted in the laa and left ventricle and the patient's hemodynamics began to suffer.Both the patient's blood pressure and heart rate dropped.The patient was given pressor, and placed on maximum oxygenation.The air was monitored in the heart for a while and aspiration of bubbles was attempted but eventually went on to pass through the circulatory system.The device was not in good position after the first deployment so the physician placed the flx device back in flx ball form.While the air situation was resolving itself and the patient's hemodynamics stabilized, the physician decided to continue the procedure.The device was successful deployed after second deployment and release criteria was met.Air remained behind the device in the distal potion of the appendage.The patient was admitted under normal attention and neurological status was monitored.The following morning, the patient was reported to be doing fine and was discharged home that same day.It is believed that the air entered during a flush of the was sheath prior to entry of the wds.

• 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: 12144432
• MDR Text Key: 260827526
• Report Number: 2134265-2021-08576
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729965718
• UDI-Public: 08714729965718
• 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: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2024
• Device Model Number: M635TU70020
• Device Catalogue Number: M635TU70020
• Device Lot Number: 0027014658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR