MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number 10390

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001); Pericardial Effusion (3271)

Event Date 11/08/2023

Event Type  Injury  

Event Description

It was reported that a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman fxd dbl curve access system (was) was inserted into the laa, and a 35mm watchman flx closure device was advanced and deployed.After several recaptures, the patient's blood pressure dropped, and a pericardial effusion was noted on transesophageal echocardiography (tee).The location of the pericardial effusion was not known.The procedure was aborted and pericardiocentesis was completed to treat the effusion.The patient's blood pressure improved, but blood was still pooling in the pericardium.The decision was made to take the patient to the operating room (or) for a sternotomy and repair of the perforation.An atrial clip was completed to treat the laa during surgery.The patient was sent to recovery and remained stable in the hospital.

• Brand Name: WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY 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: 18233643
• MDR Text Key: 329298339
• Report Number: 2124215-2023-67171
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 08714729860525
• UDI-Public: 08714729860525
• 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: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10390
• Device Catalogue Number: 10390
• Device Lot Number: 0031336038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 91 YR
• Patient Sex: Male