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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION WATCHMAN TRUSEAL ACCESS SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL Back to Search Results
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. ".

 
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Brand NameWATCHMAN TRUSEAL ACCESS SYSTEM
Type of DeviceSYSTEM, 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 Key8486487
MDR Text Key141022639
Report Number2134265-2019-02845
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
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 Received04/05/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device LOT Number0023240417
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/07/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/24/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/05/2019 Patient Sequence Number: 1
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