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 Perforation (2001); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 07/15/2020

Event Type  Injury  

Event Description

It was reported there was perforation and cardiac tamponade.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 24mm watchman laa closure device & delivery system (wds) were used.Upon deployment, the distal end of the device perforated through the left atrial appendage causing a pericardial effusion.A pericardiocentesis was performed to remove blood.A surgeon also performed a sternotomy, the watchman device was removed from the appendage and the appendage was clipped.The patient is reported to be stable.

Event Description

It was reported there was perforation and cardiac tamponade.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 24mm watchman laa closure device & delivery system (wds) were used.Upon deployment, the distal end of the device perforated through the left atrial appendage causing a pericardial effusion.A pericardiocentesis was performed to remove blood.A surgeon also performed a sternotomy, the watchman device was removed from the appendage and the appendage was clipped.The patient is reported to be stable.It was further reported that the device was placed too distally and the ostium measured 17mm to 21mm wide.

• 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: 10373750
• MDR Text Key: 201885627
• Report Number: 2134265-2020-09858
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 08714729838234
• UDI-Public: 08714729838234
• 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
• Report Date: 08/13/2020

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: 12/03/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0024869601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 08/06/2020
• Supplement Dates Manufacturer Received: 08/06/2020
• Supplement Dates FDA Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention