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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 Aneurysm (1708); Hematoma (1884)
Event Date 05/11/2021
Event Type  Injury  
Event Description

It was reported that a hematoma and aneurysm occurred. A left atrial appendage (laa) closure procedure was being performed. A watchman access system (was) was positioned and a watchman laa closure device & delivery system (wds) were used. The watchman closure device was successfully implanted in the laa. Post procedure, the patient experienced minor soreness and bruising around the access site. The patient was discharged on (b)(6) 2021. On (b)(6) 2021, the patient's leg swelled and the patient reported to their physician on (b)(6) 2021. The following morning, the physician analyzed the patient's leg via a sonogram and hospitalized the patient until (b)(6) 2021. After reviewing the sonogram, a nerve and vein specialist was called in to advise the physician where to close the hole. The patient was scheduled to have a follow up sonogram of the area mentioned on an unknown date. The patient was also scheduled for a 45 day follow up on (b)(6) 2021 and another follow up appointment with the nerve and vein specialist on (b)(6) 2021.

 
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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 Key11977542
MDR Text Key255946872
Report Number2134265-2021-07125
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,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 06/10/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/10/2021
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 Number0026874543
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/25/2021
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: 06/10/2021 Patient Sequence Number: 1
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