MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN TRUSEAL ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Lot Number	0022723190
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Thrombosis (2100); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	06/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a pericardial effusion occurred.A watchman access system (was) single curve and 24mm watchman laa closure device & delivery system (wds) were selected for use during a left atrial appendage (laa) closure procedure.After the transseptal puncture was performed with a non-bsc system, a 0.8cm pericardial effusion was noticed.The pericardial effusion was stable allowing the case to continue.The 24mm closure device was successfully implanted with one partial recapture.Patients blood pressure continued to decrease for which a pericardiocentesis was performed to remove 800 cc of fluid from the pericardium.At this time, the effusion was no longer visible on echocardiogram, but patients blood pressure remained low.Protamine was administered and the drain was left in place.A clot was then seen forming in the pericardial space and on the right atrial lead.The effusion restarted growing and pressure continued to drop periodically.Patient was transported to surgery for a sternotomy and a perforation was found to the right atrial appendage.Pericardial effusion was resolved with a suture and patients pressure stabilized.No further complications were reported.Physician believed the effusion was caused by the transseptal sheath getting caught on the ra lead.The patient is stable and has been discharged.

• Brand Name: WATCHMAN TRUSEAL 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: 8760053
• Report Number: 2134265-2019-07532
• Device Sequence Number: 16564105
• Product Code: DQY
• UDI-Device Identifier: 08714729965701
• UDI-Public: 08714729965701
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 07/03/2019

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: 09/28/2021
• Device Lot Number: 0022723190
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 07/03/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention