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	Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	10/08/2020
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 closure device was deployed in a distal position.While the physician was attempting a partial recapture they lost control of the system which caused it to advance forward significantly in the laa.The system was retracted and the device was redeployed in the patient while an effusion check was being performed.At this time the patients blood pressure began to drop, and the physician noted that there was a pericardial effusion.The physician performed a pericardiocentesis where around 400cc of blood was aspirated from the pericardial space and then reinfused back into the patient.The patient also received a blood transfusion to help with the effusion as well.The patient remained stable and also received protamine.The effusion was stable, but the patient was taken to the operating room for further examination.While in the or the patients chest was opened and it was noted that the feet of the device were poking out of a thin layer of tissue in the laa.The closure device was removed from the patient and the laa was surgically sutured by the physician.The patient did well following this surgery and remained stable.The patient was doing fine the next morning and was planned to be discharged home.

• 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: 10757160
• Report Number: 2134265-2020-14866
• Device Sequence Number: 3883979
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2020

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: 07/07/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0024071452
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2020
• Initial Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention