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

Lot Number 0023240417

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

Patient Problems Death (1802); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 03/07/2019

Event Type  Death  

Event Description

It was reported a perforation with pericardial effusion and death occurred.A left atrial appendage (laa) closure procedure was being performed.The trans-septal puncture (tsp) was complicated.The atrium was noted to be severely dilated.8000 units of heparin was administered.Immediately following the tsp a slight pericardial effusion was observed on the transesophageal echocardiogram (tee).The watchman truseal access system was introduced into the laa.It was noted the laa was too large for implant.The laac procedure was aborted and the access system was removed.The pericardial effusion continued to increase.The patient's activated clotting time (act) was 230sec.4000 units of protamine was administered.Pericardiocentesis was performed; the act was now 143sec.Blood continued to be drained from the patient and multiple erythrocyte concentrate units were administered.A transfer to another facility was requested for surgery, but the patient was not stable enough.Therefore, the surgical team from the other facility came to the implanting facility and open heart surgery was performed.During surgery it was noted the patient's heart tissue was extremely fragile and no suture would hold, any action immediately resulted in further tearing of the surrounding tissue.A total of 33 erythrocyte concentrates and 18 ffps were administered.The patient was transferred to the intensive care unit, but passed away a half hour after the surgery.Per the physician, the cause of death was pericardial tamponade.The cause of the tamponade was related to the patient's underlying condition; "the severe terminal congestive heart failure in severe pulmonary arterial hypertension tricuspid iii grades and consecutive liver cirrhosis cardiac with radiologically and clinically / visually massively dilated heart are considered.".

• Brand Name: WATCHMAN TRUSEAL ACCESS 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8486487
• MDR Text Key: 141022639
• Report Number: 2134265-2019-02845
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2022
• Device Lot Number: 0023240417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention