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

Model Number	M635TU70010
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	03/25/2021
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.The entire procedure was guided by intracardiac echocardiogram (ice) not transesophageal echocardiogram (tee).A watchman truseal access system (was) was positioned and multiple watchman flx laa closure device & delivery systems (wds) were used.In the first three deployment attempts each device landed far too proximal and the implanter was unsuccessful in advancing the flx ball deep enough to eliminate a prominent shoulder.The patient was under local anesthesia and there was significant respiratory variation during each deployment.On the final device attempt, the physician had advanced the was, with the pigtail catheter, deeper than in previous attempts.A perforation and subsequent pericardial effusion was noted on angiogram during deployment of the fourth device while in the flx ball state.It is unclear if the perforation occurred due to recapture of the third device or due to the was positioning on the final attempt.The physician immediately recaptured the device and began the process for a pericardiocentesis.Ultimately, no watchman device was implanted.The patient was taken to surgery to repair the laa perforation and the laa was clipped with a non-boston scientific device.The patient was reported to be recovering well post-surgery.The following day the physician reported the patient had been extubated and was doing "fantastic".

• 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: 11690704
• Report Number: 2134265-2021-04789
• Device Sequence Number: 3610243
• Product Code: DQY
• UDI-Device Identifier: 08714729965701
• UDI-Public: 08714729965701
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/19/2021

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: 11/12/2023
• Device Model Number: M635TU70010
• Device Catalogue Number: M635TU70010
• Device Lot Number: 0026347779
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 04/19/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR