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

Model Number	M635TU70010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	02/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that thrombosis occurred.A left atrial appendage closure procedure was performed.After crossing the interatrial septum with the watchman truseal access system (was), the sheath was inadvertently pulled back into the right atrium when removing the guidewire and a clot formed on the was sheath.The was sheath was removed and flushed.A new transseptal puncture was performed and after inserting the was sheath into the right atrium, a clot formed again.According to the physician, the roughness of the was sheath was most likely the cause of the thrombus.No further information is available at this time.
Event or Problem Description
It was reported that thrombosis occurred.A left atrial appendage closure procedure was performed.After crossing the interatrial septum with the watchman truseal access system (was), the sheath was inadvertently pulled back into the right atrium when removing the guidewire and a clot formed on the was sheath.The was sheath was removed and flushed.A new transseptal puncture was performed and after inserting the was sheath into the right atrium, a clot formed again.According to the physician, the roughness of the was sheath was most likely the cause of the thrombus.No further information is available at this time.It was further reported that the procedure was aborted and the watchman device was never deployed or implanted.The thrombosis located in the right side of the heart was treated with heparin and the was removed.

• 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: 13660524
• Report Number: 2134265-2022-02390
• Device Sequence Number: 19318980
• Product Code: DQY
• UDI-Device Identifier: 08714729965701
• UDI-Public: 08714729965701
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 03/24/2022

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: 03/03/2024
• Device Model Number: M635TU70010
• Device Catalogue Number: M635TU70010
• Device Lot Number: 0026910934
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown