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

Model Number 10390

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

Patient Problems Perforation (2001); Pericardial Effusion (3271)

Event Date 08/11/2021

Event Type  Injury  

Event Description

It was reported that a perforation and pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 27mm watchman flx laa closure device & delivery system (wds) were used.The was positioned in the laa and the wds was inserted in.The closure device was deployed and after confirming release criteria was met the device was released from the core wire.After the device had been released the physician noted that there was blood in the pericardial space.The patient had a pericardial effusion.The physician performed a pericardiocentesis and removed 500cc of blood from the patient.At this time the patient stabilized.Transthoracic echocardiogram imaging showed the pericardial effusion had decreased in size.45 to 60 minutes later the physician felt the bleeding was not stopped and decided to bring the patient to surgery to repair the perforation.During surgery while trying to repair the tear the closure device was dislodged.The surgeon removed the watchman closure device from the patient and then ligated the laa.The patient has since recovered from these events and was set to be discharged from the hospital.

• Brand Name: WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM
• Type of Device: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12417672
• MDR Text Key: 269661261
• Report Number: 2134265-2021-11157
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 08714729860501
• UDI-Public: 08714729860501
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/02/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2024
• Device Model Number: 10390
• Device Catalogue Number: 10390
• Device Lot Number: 0027351310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR