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

Model Number	M635TU70020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that thrombosis occurred.A left atrial appendage (laa) closure procedure was performed.7000 units of heparin were given.During formation of the flex ball inside the laa it was noticed that a clot was forming on the watchman truseal access system (was).The watchman delivery system was pulled back and then it was attempted to aspirate from the was, which did not work.Then the was was pulled back into the right atrium and out of the body taking the clot with it.At this point the activated clotting time (act) was 239 seconds and another 3000 units of heparin were given.It was then noticed there was a clot on the septum in the right atrium when crossing back across the septum but it was decided to proceed since it was on the right side.It was then noticed that the clot was no longer there.The watchman device was successfully implanted meeting anchoring criteria.The patient has fully recovered.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15284707
• Report Number: 2124215-2022-31817
• Device Sequence Number: 11361002
• Product Code: DQY
• UDI-Device Identifier: 08714729965718
• UDI-Public: 08714729965718
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/24/2022

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: 03/22/2025
• Device Model Number: M635TU70020
• Device Catalogue Number: M635TU70020
• Device Lot Number: 0029095964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2022
• 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 Age: 79 YR
• Patient Sex: Female