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

Model Number	M635TU70040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Thrombosis/Thrombus (4440)
Date of Event	06/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a thrombosis was suspected.A left atrial appendage (laa) closure procedure was being performed.A watchman truseal anterior curve access system (was) was positioned and a 24mm watchman flx laa closure device & delivery system (wds) were used.It was suspected that a thrombus formed on the distal end of the was once the device was placed into the heart.Eliquis was injected into the patient's heart to break up the thrombus, and the patient was subsequently given heparin.The closure device initially did not meet release criteria, so it was partially recaptured and redeployed.Post implant, it was noticed that the puncture site was bleeding, in which the nurses applied pressure to the site to stop the bleeding.The patient stayed in the hospital overnight, and was discharged home the following day with a pressure dressing applied to the incision site.It was also noted that the closure device was sitting in the laa at an angle.The patient scheduled follow up appointments with their regular cardiologist set for two weeks post procedure and with the implanting physician one month post procedure.

• 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
• MDR Report Key: 12108832
• Report Number: 2134265-2021-08157
• Device Sequence Number: 4180117
• Product Code: DQY
• UDI-Device Identifier: 08714729965725
• UDI-Public: 08714729965725
• Combination Product (Y/N): N
• 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: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/02/2021

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: 03/17/2024
• Device Model Number: M635TU70040
• Device Catalogue Number: M635TU70040
• Device Lot Number: 0026993299
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/02/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention