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	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a perforation and a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman truseal access system (was) was positioned and a 21mm watchman laa closure device & delivery system (wds) were used.The was was positioned in the laa.The was was deep seated, but well buffered by the pigtail, and the sheath remained in the same position upon removal of the pigtail catheter.When the closure device was deployed, it appeared the feet of the device jumped forward as the shoulders were unsheathed.Angiography revealed a perforation/pericardial effusion noted distal to the feet of the device by contrast leaking into the pericardium in the area of the transverse sinus and posterior cavity.Protamine was immediately administered to reverse heparin.The device was released in the laa after all release criteria was noted to be met.A pericardiocentesis was attempted to treat the pericardial effusion, however, a fluid return could not be seen as there was such a minimal effusion.The effusion was monitored with transesophageal echocardiography (tee) for 30 minutes post procedure and never increased in size.The patient was stable the entire procedure and is expected to fully recover.

• 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: 11665711
• Report Number: 2134265-2021-03854
• Device Sequence Number: 14227549
• Product Code: NGV
• UDI-Device Identifier: 08714729838227
• UDI-Public: 08714729838227
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 04/14/2021

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: 11/20/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0024805036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/14/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR