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 Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	04/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a perforation and a pericardial effusion.A left atrial appendage (laa) closure procedure was being performed.The anatomy was noted to be difficult and chicken wing in shape.They attempted both an anterior curve and then a single curve watchman access system (was) for adequate positioning.A 27mm watchman laa closure device was deployed but did not meet release criteria.The device was recaptured.They decided to re-cross the septum in a different position.The physician felt that there was a little extra resistance with the transseptal sheath when the re-cross was performed.After this was performed a perforation occurred.The physician saw a small pericardial effusion both on inter-cardiac echo and transesophageal echo.Ultimately the patient was monitored.Their blood pressure did drop a little bit but there was never a tamponade that occurred.A pericardiocentesis was performed which removed 200cc of blood.After that, there was no more attempt to implant the device because protamine had been given.The physician did not want to heparinize any longer.The procedure was cancelled.The patient was stable following these events.

• 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: 8577159
• Report Number: 2134265-2019-04485
• Device Sequence Number: 19291758
• Product Code: NGV
• UDI-Device Identifier: 08714729838197
• UDI-Public: 08714729838197
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 05/03/2019

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: 08/27/2020
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0021061859
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 05/03/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention