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	10/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pericardial effusion and tamponade occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 33mm watchman laa closure device & delivery system (wds) were used.The 33mm device was successfully inserted into the laa after one partial recapture was performed.After the procedure there was no effusion present and protamine was not given after the case.Two hours post-procedure, the patient began to experience tamponade.A pericardiocentesis was performed, a pericardial drain was placed and the patient was stabilized.The patient fully recovered and was discharged.The patient returned to the clinic on (b)(6) 2020 for a follow-up visit and was reported to be stable.

• 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: 10927474
• Report Number: 2134265-2020-16465
• Device Sequence Number: 11835940
• Product Code: NGV
• UDI-Device Identifier: 08714729838265
• UDI-Public: 08714729838265
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/01/2020

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: 02/12/2023
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0025207987
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 12/01/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention