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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 M635TU70040
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Thrombosis/Thrombus (4440)
Event Date 06/08/2021
Event Type  Injury  
Event Description

It was reported that a thrombosis was suspected. A left atrial appendage (laa) closure procedure was being performed. A watchman truseal anterior curve access system (was) was positioned and a 24mm watchman flx laa closure device & delivery system (wds) were used. It was suspected that a thrombus formed on the distal end of the was once the device was placed into the heart. Eliquis was injected into the patient's heart to break up the thrombus, and the patient was subsequently given heparin. The closure device initially did not meet release criteria, so it was partially recaptured and redeployed. Post implant, it was noticed that the puncture site was bleeding, in which the nurses applied pressure to the site to stop the bleeding. The patient stayed in the hospital overnight, and was discharged home the following day with a pressure dressing applied to the incision site. It was also noted that the closure device was sitting in the laa at an angle. The patient scheduled follow up appointments with their regular cardiologist set for two weeks post procedure and with the implanting physician one month 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 Key12108832
MDR Text Key259667192
Report Number2134265-2021-08157
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 07/02/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/02/2021
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 Number0026993299
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/18/2021
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: 07/02/2021 Patient Sequence Number: 1
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