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

Model Number	10373
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	09/27/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) and a 21mm watchman laa closure device & delivery system (wds) were used.The procedure was completed with no complications and the closure device was successfully implanted.After the procedure was completed it was noticed that there was an effusion.The physicians attempted a pericardiocentesis to drain the blood, but they were unsuccessful.The patient then went to the operating room where they performed a pericardial window, but still could not stop the bleeding.The physicians then did a sternotomy and they were successful in the stopping the bleeding.The patient made a full recovery and was discharged home.
Event or Problem Description
It was reported that a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) and a 21mm watchman laa closure device & delivery system (wds) were used.The procedure was completed with no complications and the closure device was successfully implanted.After the procedure was completed it was noticed that there was an effusion.The physicians attempted a pericardiocentesis to drain the blood, but they were unsuccessful.The patient then went to the operating room where they performed a pericardial window, but still could not stop the bleeding.The physicians then did a sternotomy and they were successful in the stopping the bleeding.The patient made a full recovery and was discharged home.It was further reported that the surgeon performed a sternotomy and located the bleed.The surgeon then placed 1-2 stitches on the back wall of the appendage and the bleeding completed stopped.The patient made a full recovery and is doing well.

• Brand Name: WATCHMAN ACCESS 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: 7979445
• Report Number: 2134265-2018-62032
• Device Sequence Number: 19177943
• Product Code: NGV
• UDI-Device Identifier: 08714729838197
• UDI-Public: 08714729838197
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2018

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: 06/13/2021
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0022250877
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 11/29/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR