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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 Cardiac Arrest (1762); Death (1802); Fistula (1862)
Event Date 06/29/2020
Event Type  Death  
Event Description

It was reported that there was a patient death. On (b)(6) 2020 a left atrial appendage (laa) closure procedure was being performed. A watchman truseal access system (was) was positioned and a 30mm watchman laa closure device & delivery system (wds) were used. The procedure was completed successfully and the closure device was implanted in the laa of the patient. The patient had an angiogram of the lower extremity which revealed an av fistula in their groin and was sent to surgery for repair but the patient continued to decline. The patient had bleeding, low pressure and suffered a cardiac arrest. They passed away four days post procedure.

 
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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 Key10321265
MDR Text Key200259715
Report Number2134265-2020-09646
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 07/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/24/2020
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 Number0025096420
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 Received07/06/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/24/2020
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: 07/24/2020 Patient Sequence Number: 1
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