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

Model Number TU-8002

Device Problem Difficult to Insert (1316)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 08/25/2023

Event Type  Injury  

Event Description

It was reported a procedural thrombus occurred.A left atrial appendage (laa) closure procedure was being performed using a watchman fxd curve access system (was).After completion of the transeptal puncture, resistance was encountered during insertion of the was into right femoral vein but insertion was ultimately successful.A thrombus was observed via transesophageal echocardiogram (tee) on the leads of the permanent pacemaker.It was noted the patient had a hypercoagulation issue.The procedure was not completed and the patient was discharged the same day.The patient will come back for a one month follow up to determine if another laa closure procedure is an option.

• Brand Name: WATCHMAN FXD CURVE ACCESS SYSTEM
• Type of Device: 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17712551
• MDR Text Key: 322982482
• Report Number: 2124215-2023-46538
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00191506013813
• UDI-Public: 00191506013813
• 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: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• 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
• Device Lot Number: 0031133041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Race: White