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

Model Number	10371
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	08/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that perforation, pericardial effusion, and cardiac tamponade occurred.A left atrial appendage (laa) closure procedure was being performed.During placement of the watchman truseal access system (was) a 5f pigtail catheter was placed in the laa with difficulty during advancement over a stiff guidewire.The initial attempt at deployment of the 27mm watchman laa closure device was aborted because sheath placement was too proximal during unsheathing.The device was partially deployed with the feet of the device minimally exposed and was recaptured.An effusion sweep was performed and the sweep revealed a pericardial effusion.An angiogram was performed and perforation was noted.Initially, the patient's vital signs were stable but then became hypotensive.A pericardiocentesis was performed and the patient was taken to the operating room for surgical repair.There was suspicion that the difficult placement of the pigtail and stiff guidewire contributed to the perforation.Additionally, the tip of the was noted to have a tear.No additional information is known at this time.
Event or Problem Description
It was reported that perforation, pericardial effusion, and cardiac tamponade occurred.A left atrial appendage (laa) closure procedure was being performed.During placement of the watchman truseal access system (was) a 5f pigtail catheter was placed in the laa with difficulty during advancement over a stiff guidewire.The initial attempt at deployment of the 27mm watchman laa closure device was aborted because sheath placement was too proximal during unsheathing.The device was partially deployed with the feet of the device minimally exposed and was recaptured.An effusion sweep was performed and the sweep revealed a pericardial effusion.An angiogram was performed and perforation was noted.Initially, the patient's vital signs were stable but then became hypotensive.A pericardiocentesis was performed and the patient was taken to the operating room for surgical repair.There was suspicion that the difficult placement of the pigtail and stiff guidewire contributed to the perforation.Additionally, the tip of the was was noted to have a tear.No additional information is known at this time.It was further reported that the patient was out of bed the morning after surgery and recovered.

• 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: 12421764
• Report Number: 2134265-2021-11180
• Device Sequence Number: 14279937
• Product Code: NGV
• UDI-Device Identifier: 08714729838241
• UDI-Public: 08714729838241
• 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,Followup
• Report Date (Section B): 09/15/2021

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: 10/10/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0024583833
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 09/15/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR