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

Model Number	M635TU70040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130)
Date of Event	05/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that ventricular fibrillation and hypotension occurred.A left atrial appendage (laa) closure procedure was being performed.After transseptal puncture and when the wire was in the left upper pulmonary vein (lupv) with the anterior curve watchman truseal access system (was), the patient experienced ventricular fibrillation (vf) and their blood pressure dropped.The patient was shocked with a defibrillator and their heart rate and blood pressure resumed to normal.After the wire was removed and the pigtail was inserted into the was, the was was adjusted from across the mitral valve to mid left atrium (la), and the patient experienced vf and their blood pressure dropped again.The patient was shocked again, but the patient went into ventricular arrhythmia and ventricular fibrillation because the staff did not sync the defibrillator.Once the defibrillator was properly synced, the patient's heart rate and blood pressure resumed normal again.A 24mm watchman flx laa closure device & delivery system (wds) was used and the closure device was successfully implanted.The patient was discharged the following day on (b)(6) 2021.

• 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: 12011138
• Report Number: 2134265-2021-07127
• Device Sequence Number: 3304729
• Product Code: DQY
• UDI-Device Identifier: 08714729965725
• UDI-Public: 08714729965725
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/16/2021

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: 01/28/2024
• Device Model Number: M635TU70040
• Device Catalogue Number: M635TU70040
• Device Lot Number: 0026715308
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 06/16/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR