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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
Model Number M635TU70020
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Cardiac Perforation (2513); Pericardial Effusion (3271)
Event Date 04/03/2020
Event Type  Death  
Event Description

It was reported that a patient death occurred. A left atrial appendage (laa) closure procedure was being performed. A watchman access system (was) was positioned and a 27mm watchman laa closure device & delivery system (wds) were used. When gaining left femoral venous access and doing the transseptal puncture, there was some resistance when passing the wire and sheath past the iliac artery. In order to prevent any possibly kinks with the watchman double curve access sheath (was), a 16 f sheath was inserted into the groin and the was inserted through the 16 f sheath and into the left atrium. Once gaining access into the left atrium, heparin was given. The was and pigtail were positioned into the anterior lobe of the laa. The pigtail was removed from the was and the was did not change position, but was deep in the laa. As the 27 mm device was advanced through the was, it was noted the was should be pulled back for safety. Instead of pulling the was back out of the laa, the was advanced further and anteriorly. It was believed the was perforated the laa, the physician had the echocardiographer search for an effusion while they simultaneously connected the manifold to the was. An effusion was found and the was tip was outside of the laa. Since the device was already within the was, the physician wanted to pull the was back and deploy the device in an effort to slow the effusion. The physician chose to deploy the device and proceeded to perform a pericardiocentesis immediately. While tapping the patient, a call for ct surgery backup was made. The on call surgeon was at home approximately 20-25 minutes away. There were two units of blood in the room that were immediately set up along with fluids. Echo showed the effusion growing and the patients heart was beginning to tamponade. The amount of blood withdrawn from the pericardium is unknown due to quickly withdrawing blood and performing auto transfusions. When the patient was stable enough, the device was checked on echo to make sure it was in the laa. It was slightly distal to the ostium with a small leak shown on echo, and what appeared to be adequate compression via fluoroscopy showing the device shape. The device was released off the core wire and once the was/wds system was removed from the left side of the heart, protamine was given. Because the blood in pericardium started to clot, the patients heart function and blood pressure decreased over time. Cpr was performed to stabilize the patient. The patients belly distended extensively due to bleeding. Cardiothoracic surgery assessed the situation and it was chosen not to proceed with surgical intervention. The patient ultimately expired.

 
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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 CORPORATION
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9996670
MDR Text Key188861858
Report Number2134265-2020-05302
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 04/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/24/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM635TU70020
Device Catalogue NumberM635TU70020
Device LOT Number0024804605
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 Received04/03/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/20/2019
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: 04/24/2020 Patient Sequence Number: 1
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