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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); Hematoma (1884)
Event Date 10/17/2020
Event Type  Death  
Event Description

It was reported that a hematoma and death occurred. A left atrial appendage (laa) closure procedure was performed and a watchman truseal access system (was) was positioned and a 24mm watchman laa closure device was used. The device met release criteria with 20. 8-25% compression, great tug test, and no leak. The activated clotting time (act) during the procedure was 231. The following day, prior to discharge, the patient developed leg pain. A hematoma was noted at the watchman access site. The patient was asymptomatic. The patient got out of bed, and his blood pressure dropped. A possible stroke was suspected and a computed tomography (ct) scan was ordered but stroke was not confirmed. A vascular surgeon was notified and the patient remained in the hospital. On (b)(6) 2020, an interventional radiology procedure was performed and an injection noted a hematoma and blood loss. On (b)(6) 2020, the patient underwent surgery to repair the hematoma and died.

 
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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 Key11131848
MDR Text Key225527113
Report Number2134265-2020-18716
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 01/07/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/07/2021
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 Number0025897109
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 Received12/18/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/21/2020
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: 01/07/2021 Patient Sequence Number: 1
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