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	01/14/2021
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 access system (was) was positioned and a 21mm watchman laa closure device & delivery system (wds) were used.The device was deployed and one partial recapture was required.The device met release criteria and was released.Post-case transesophageal echo (tee) sweeps did not show any effusion.Two hours post-implant, a pericardial effusion was noted.The patient went to the operating room and had a stitch placed at the descending end of the laa.There was a small tear from the feet of the watchman device.The patient is reported to be doing well.

• 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: 11274559
• Report Number: 2134265-2021-00999
• Device Sequence Number: 14522972
• Product Code: NGV
• UDI-Device Identifier: 08714729838227
• UDI-Public: 08714729838227
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/03/2021

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: 11/10/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0024751609
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 02/03/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention