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

Model Number 10371

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Pericardial Effusion (3271)

Event Date 12/06/2019

Event Type  Injury  

Event Description

It was reported that a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 33mm watchman laa closure device & delivery system (wds) were used.The procedure was completed successfully and the closure device was implanted in the laa of the patient.There were no pericardial effusions found pre or immediately post procedure and no complications that occurred during the procedure.20 minutes post procedure the patient developed a pericardial effusion.The physician performed a pericardiocentesis to treat the effusion.

Event Description

It was reported that a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 33mm watchman laa closure device & delivery system (wds) were used.The procedure was completed successfully and the closure device was implanted in the laa of the patient.There were no pericardial effusions found pre or immediately post procedure and no complications that occurred during the procedure.20 minutes post procedure the patient developed a pericardial effusion.The physician performed a pericardiocentesis to treat the effusion.It was further reported that the patient presented with a pericardial effusion a few hours post procedure.The patient was taken to the operating room and needed ecmo support.On (b)(6) 2019 the patient was still currently in the hospital, but was being decannulated from ecmo.The patients neurological status is improving.

Event Description

It was reported that a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 33mm watchman laa closure device & delivery system (wds) were used.The procedure was completed successfully and the closure device was implanted in the laa of the patient.There were no pericardial effusions found pre or immediately post procedure and no complications that occurred during the procedure.20 minutes post procedure the patient developed a pericardial effusion.The physician performed a pericardiocentesis to treat the effusion.It was further reported that the patient presented with a pericardial effusion a few hours post procedure.The patient was taken to the operating room and needed ecmo support.On (b)(6)2019 the patient was still currently in the hospital, but was being decannulated from ecmo.The patients neurological status is improving.It was further reported that the patient had a cardiac arrest when they were on the medical floor they were taken to the operating room and the pericardial effusion was drained.They were then placed on ecmo at some point while in the operating room.The patient remained in the hospital and has minimal neurological response.

• Brand Name: WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
• Type of Device: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9474898
• MDR Text Key: 170930926
• Report Number: 2134265-2019-15752
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 08714729838265
• UDI-Public: 08714729838265
• Combination Product (y/n): N
• PMA/PMN Number: P130013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0023569621
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 12/18/2019; 01/15/2020
• Supplement Dates FDA Received: 12/23/2019; 02/04/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR