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

Model Number	10371
Health Effect - Clinical Codes	Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	01/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a perforation, pericardial effusion and cardiac tamponade occurred.A left atrial appendage (laa) closure procedure was being performed.No baseline effusion was detected prior to the procedure.A watchman access system (was) was positioned and a watchman laa closure device & delivery system (wds) were used.The septum was crossed using standard procedure and no effusion was noted post crossing.The first device was deployed too proximal and recaptured.An effusion check was clear.A second device was deployed but failed the tug test and was fully recaptured.An effusion check was clear.A third 33mm device was deployed and an immediate effusion was noted by the echo physician.A perforation of the distal laa occurred leading to cardiac tamponade.A clinically significant blood pressure drop was noted when the effusion developed and increased in size.A pericardiocentesis was performed and the effusion was minimized.The physician rechecked the device and attempted a tug test but it failed and the device was removed.The effusion increased once the device was removed.Pericardiocentesis continued and when the patient was stabilized, she was transferred to an operating room lab.A sternotomy was done, the pericardial space was evacuated, and the laa was clipped.The patient was stable and has been discharged.

• Brand Name: WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11337507
• Report Number: 2134265-2021-01688
• Device Sequence Number: 14323533
• Product Code: NGV
• UDI-Device Identifier: 08714729838265
• UDI-Public: 08714729838265
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2021

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: 01/11/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0023176198
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 02/17/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention