• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION WATCHMAN TRUSEAL ACCESS SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL Back to Search Results
Model Number M635TU70040
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Air Embolism (1697); Transient Ischemic Attack (2109)
Event Date 03/18/2020
Event Type  Injury  
Event Description

It was reported that a stroke occurred. A left atrial appendage (laa) closure procedure was being performed. A watchman access system (was) was positioned and three watchman laa closure devices were attempted; however, the procedure was aborted due to the inability to meet the release criteria. Post-procedure, the patient appeared to have tia-like symptoms. The symptoms occurred shortly after the patient was sat up in bed which led the physician to believe there was a transient ischemic attack or stroke caused by air. The symptoms resolved and the patient had no residual affects and was symptom free. The physician reviewed fluoroscopy films and believes he could see something that could potentially be an air bubble. The equipment in the patient at the time the air bubble was seen was the was sheath. No brain imaging was performed.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9959240
MDR Text Key187615121
Report Number2134265-2020-04452
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 04/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/14/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM635TU70040
Device Catalogue NumberM635TU70040
Device LOT Number0024588026
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 Received03/20/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/13/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/14/2020 Patient Sequence Number: 1
-
-