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	Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	09/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that perforation, pericardial effusion, and cardiac tamponade occurred.A left atrial appendage (laa) closure procedure was being performed.Prior to the procedure, a baseline trivial pericardial effusion (pe) was noted to measure 2-3mm.The fellow physician attempted the initial transseptal puncture, but access to the left side was lost shortly after crossing.The implanting physician performed the second transseptal crossing, but encountered difficulty navigating safely into the vein.He re-attempted for a third crossing in a more favorable location mid-septum but the wire would still not enter the vein.It was then decided to utilize a different non-boston scientific corporation (bsc) transseptal crossing guidewire with a curled tip which required a fourth transseptal cross and a sheath exchange.The fourth transseptal cross was successful and allowed the physician to navigate the watchman truseal access system (was) single curve sheath into the left side.A pigtail then went in over the guidewire and the guidewire was removed.The pigtail and was sheath tip slowly navigated into the laa when the physician noticed a lateral pe, notably larger than the initial pe, measuring 6mm.It was decided to remove the devices and reverse the patient who was on heparin, by administering protamine.Initially, the patient had no hemodynamic changes and the pe was noted to be unchanged for 20 minutes.The patient then began to decompensate with an increase in blood pressure and heartrate.The patient was cardioverted for rhythm management and a pericardiocentesis was performed with successful drain placement at the apical portion of the heart where 500ml of blood was drained.The patient was administered 2 units of blood.The drain was kept in place while the patient was transferred to the intensive care unit for recovery.The pe was alleviated with the drain and hemodynamics stabilized.The patient was expected to fully recover.

• 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: 12528209
• Report Number: 2134265-2021-11778
• Device Sequence Number: 19859250
• Product Code: DQY
• UDI-Device Identifier: 08714729965701
• UDI-Public: 08714729965701
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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: 06/03/2022
• Device Model Number: M635TU70010
• Device Catalogue Number: M635TU70010
• Device Lot Number: 0023895506
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 09/24/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR