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

Model Number	10373
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	11/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a pericardial effusion and tamponade occurred.A left atrial appendage (laa) closure procedure was being performed.After transseptal puncture, a double curve watchman access system (was) was inserted with a pigtail catheter.The left atrial appendage (laa) was unable to be accessed, so the double curve and pigtail were removed.The pigtail catheter and an anterior curve was were inserted; however, the anterior curve was kinked, so the anterior curve was and pigtail were removed.A new transseptal puncture was performed to better align with the laa.A new anterior curve was and pigtail were inserted.Good position for deployment was achieved, and a watchman laa closure device and delivery system (wds) was inserted and the closure device was deployed.The position did not meet release criteria so the device was recaptured.The pigtail was reinserted and good position was achieved again.A new watchman closure device was inserted, but the position was lost and the device was removed and replaced with a pigtail.The pigtail catheter was used to take another contrast injection and showed no signs of perforation.More manipulation was attempted to get to a desirable position, and another contrast shot was taken and staining of the pericardium was noted.An effusion was confirmed at this time.Heparin was reversed, the was and pigtail were pulled back to the inferior vena cava, and a pericardiocentesis was performed.After draining the blood and stabilizing the patient, the patient was moved to the operating room for a pericardial window procedure to further assess the effusion.No further interventions were performed.The patient has been discharged.

• Brand Name: WATCHMAN 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: 10943320
• Report Number: 2134265-2020-16661
• Device Sequence Number: 16998937
• Product Code: NGV
• UDI-Device Identifier: 08714729838210
• UDI-Public: 08714729838210
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 12/03/2020

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: 03/09/2023
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0025328034
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 12/04/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR