MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number	10371
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	05/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a perforation, pericardial effusion, and hypotension occurred.A left atrial appendage (laa) closure procedure was being performed.After transseptal puncture, an anterior curve watchman access system (was) was introduced to the laa with a pigtail catheter, and heparin was given post transseptal puncture.The anterior curve was had difficulty tracking over the pigtail wire into the anterior lobe of the laa, and after 10-15 minutes, the anterior curve was removed from the patient.A single curve watchman access system (was) was then positioned and a 21mm watchman laa closure device & delivery system (wds) were used.The release criteria were met and the closure device was successfully implanted.There was no pericardial effusion noted post device release.Hemostasis was then achieved with a non-boston scientific vascular closure device and light pressure post heparin reversal.The patient's blood pressure then dropped and the patient became unstable 30 minutes post procedure.A pericardial effusion was noted via intracardiac echocardiography (ice), which was caused by a cardiac perforation.Pericardiocentesis was performed, and 300 ml of blood was removed from around the pericardium.The patient was observed for 45 minutes post pericardiocentesis and became stable.The patient was moved to the intensive care unit (icu) and the patient's condition improved.Echocardiography was performed, which showed the effusion was no longer present.The patient was discharged home on (b)(6) 2021.

• Brand Name: WATCHMAN LAA CLOSURE DEVICE & DELIVERY 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: 12001458
• Report Number: 2134265-2021-07314
• Device Sequence Number: 1099636
• Product Code: NGV
• UDI-Device Identifier: 08714729838227
• UDI-Public: 08714729838227
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 06/15/2021

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: 11/05/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0024720138
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 06/15/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR