• 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 M635TU70020
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)
Event Date 08/06/2021
Event Type  Injury  
Event Description

It was reported that the patient had a hematoma. A left atrial appendage (laa) closure procedure was being performed. A watchman truseal access system (was) was positioned and a 24mm watchman flx laa closure device & delivery system (wds) were used. During the procedure a 20mm watchman flx device was deployed but did not meet release criteria. This device was fully recaptured and removed from the patient. The physician then successfully completed the procedure by implanting a new 24mm watchman flx device in the laa of the patient. There were no complications that occurred during the procedure. After the procedure was completed the patient developed a groin hematoma that required manual pressure to be applied. The patient also experienced a low blood pressure at this time. A thrombin injection was given to the patient but it did not resolve the hematoma. So, the patient was brought to the operating room to repair the femoral artery. In addition the patient received blood products that day. The patient has since been discharged home doing fine.

 
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 Key12388769
MDR Text Key268846076
Report Number2134265-2021-10607
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 08/30/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/30/2021
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 Number0027379196
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 Received08/09/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/25/2021
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: 08/30/2021 Patient Sequence Number: 1
-
-