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 Tamponade (2226); Pericardial Effusion (3271)
Date of Event	02/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a pericardial effusion with tamponade occurred.A left atrial appendage (laa) closure procedure was attempted.No pericardial effusion was noted prior to the procedure.Multiple watchman laa closure device and delivery systems were used.Multiple closure devices were deployed, but no closure device was implanted due to anatomical challenges and suboptimal results.The procedure was aborted and the patient was discharged home seven hours post procedure.Within one hour, the patient returned to the emergency department with a syncopal episode and right ventricle collapse.An echocardiogram showed a new moderately sized pericardial effusion with early signs of cardiac tamponade.The patient was taken promptly to the catheterization lab and underwent successful pericardiocentesis with drain placement.410 cc of sanguineous fluid was removed.The patient has pleuritic chest pain, but his breathing has improved.The patient remained hospitalized, but his drain was removed.

• 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: 11360933
• Report Number: 2134265-2021-02136
• Device Sequence Number: 16990144
• Product Code: NGV
• UDI-Device Identifier: 08714729838258
• UDI-Public: 08714729838258
• Combination Product (Y/N): N
• 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): 02/22/2021

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: 02/19/2023
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0025241500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 02/22/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention