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

Lot Number	0022387867
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a kink occurred causing subsequent recapture difficulty.A watchman access system (was) single curve was positioned and a 27mm watchman laa closure device & delivery system (wds) were selected for use during a left atrial appendage (laa) closure procedure.The delivery system of the first deployed closure device kinked and the closure device was fully recaptured.The delivery system of the second closure device also kinked prior to deployment.The last closure device was deployed and landed too proximally for which a full recapture was attempted.However, difficulty recapturing the device was met and the access system was pulled across the septum.The access system was noted to have kinked.Visual analysis of the device showed tissue on the anchors.Post-procedure, patient developed hypotension and a pericardial effusion and cardiac tamponade were discovered.A pericardiocentesis was performed removing 300cc of blood.Patient is stable and has been discharged home.

• 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: 9180067
• Report Number: 2134265-2019-12289
• Device Sequence Number: 2762923
• Product Code: DQY
• UDI-Device Identifier: 08714729965701
• UDI-Public: 08714729965701
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/16/2021
• Device Lot Number: 0022387867
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 10/11/2019
• Patient Sequence Number: 1
• Patient Age: 75 YR