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

Model Number TU-8002

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 12/15/2022

Event Type  Injury  

Event Description

It was reported that thrombosis occurred.A left atrial appendage (laa) closure procedure was performed using a 24mm watchman flx laa closure device with delivery system (wds) and watchman fxd curve access system (was).Following the transeptal puncture, a pigtail catheter was advanced through the was.Once the pigtail catheter was introduced into the left atrium a thrombus was identified via transesophageal echocardiogram (tee).The pigtail catheter was removed from the patient then reintroduced and the procedure continued.The closure device was placed and deployed.After deployment of the closure device, a thrombus was identified on the tip of the was sheath.The closure device was recaptured, and the thrombus was aspirated into the was.The closure device, wds, and was were all removed from the patient.The procedure recommenced and was successfully completed with the use of a new closure device, wds, and was.The patient fully recovered and was discharged one day post index procedure.

• Brand Name: WATCHMAN FXD CURVE 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
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16025121
• MDR Text Key: 305916011
• Report Number: 2124215-2022-53825
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2022

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
• Device Operator: Health Professional
• Device Model Number: TU-8002
• Device Catalogue Number: TU-8002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2022
• Initial Date FDA Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Female