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

Model Number	10373
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis (2100); Thrombosis/Thrombus (4440)
Date of Event	10/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported thrombus occurred.A left atrial appendage (laa) closure procedure was being performed.Some confusion occurred and the heparin was not administered at the correct time.It was administered four minutes after the watchman access system crossed the septum.As the 21mm watchman laa closure device and delivery system was advanced into the access system, a clot was noticed coming out of the proximal portion of the access system.The closure device was never deployed.The delivery system was removed and the physician aspirated the clot from the access system with a 60cc syringe.The clot was aspirated successfully.The access system was removed from the body.Anesthesia and the physician performed a neurological assessment on the patient after she was awake and she was noted to be fine.
Additional Manufacturer Narrative
H6: evaluation conclusion code corrected from known inherent risk of device to unintended use error caused or contributed to event.Media review: media was made available and reviewed by a member of boston scientific medical safety: two movie files of implant transesophageal echocardiogram (tee) were reviewed.The first shows the access system deep seated in laa with complex hypermobile echo density adherent to the access system after reportedly delayed heparin administration.The second is reportedly post aspiration and access system removal with no residual thrombus visible in the la/laa.
Event or Problem Description
It was reported thrombus occurred.A left atrial appendage (laa) closure procedure was being performed.Some confusion occurred and the heparin was not administered at the correct time.It was administered four minutes after the watchman access system crossed the septum.As the 21mm watchman laa closure device and delivery system was advanced into the access system, a clot was noticed coming out of the proximal portion of the access system.The closure device was never deployed.The delivery system was removed and the physician aspirated the clot from the access system with a 60cc syringe.The clot was aspirated successfully.The access system was removed from the body.Anesthesia and the physician performed a neurological assessment on the patient after she was awake and she was noted to be fine.

• Brand Name: WATCHMAN ACCESS SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 9288768
• Report Number: 2134265-2019-13380
• Device Sequence Number: 11340500
• Product Code: NGV
• UDI-Device Identifier: 08714729838210
• UDI-Public: 08714729838210
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• 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): 04/05/2024

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: 12/12/2021
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0023080318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female