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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
Lot Number 0027774632
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 02/17/2022
Event Type  Injury  
Manufacturer Narrative
Initial reporter name and address: (b)(6).
 
Event Description
(b)(6) study.It was reported that femoral puncture site bleeding occurred.The patient was enrolled into the champion-af clinical study on (b)(6) 2022, and the procedure was performed ten days later.A 24mm watchman flx left atrial appendage (laa) closure device was implanted with a complete laa seal and deployed device diameter of 18.0mm.On the same day post index procedure, bleeding was noted through the femoral puncture site.No hematoma was seen and the bleeding was noted from the superficial subcutaneous cellular tissue.Three stitches were applied to the femoral puncture site in order to stop the bleeding and a swab compression with low pressure was given.Swab compression was removed four hours later without signs of bleeding.The patient was discharged home the following day on aspirin and edoxaban.
 
Event Description
Champion-af study.It was reported that femoral puncture site bleeding occurred.The patient was enrolled into the champion-af clinical study on (b)(6) 2022, and the procedure was performed ten days later.A 24mm watchman flx left atrial appendage (laa) closure device was implanted with a complete laa seal and deployed device diameter of 18.0mm.On the same day post index procedure, bleeding was noted through the femoral puncture site.No hematoma was seen and the bleeding was noted from the superficial subcutaneous cellular tissue.Three stitches were applied to the femoral puncture site in order to stop the bleeding and a swab compression with low pressure was given.Swab compression was removed four hours later without signs of bleeding.The patient was discharged home the following day on aspirin and edoxaban.It was further reported that transthoracic echocardiography (tte) one day post procedure revealed the left ventricle (lv) was of normal size and thickness.Preserved systolic function was seen with no contractility disorders.The right ventricle (rv) was of normal size and function.The left atrium (la) was moderately dilated with intact interatrial septum (ias).The aortic valve was noted with 3 leaflets, with mild central leak.The mitral valve was noted with mild mitral insufficiency with no significant mitral stenosis (mean gradient < 3 mmhg) and tricuspid insufficiency.No pericardial effusion and pleural effusion.Noted.Twelve (12) days post procedure, the groin stiches were removed and dehiscence of the wound was noted.The patient was on aspirin (100mg) and edoxaban (30mg) at the time of this event.The patient treated this wound at home and the dehiscence was resolved ten days later.
 
Manufacturer Narrative
Describe event or problem - updated with new information.Other relevant history - updated with corrected baseline tee date.E1: initial reporter address 1 - (b)(6).
 
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Brand Name
WATCHMAN TRUSEAL ACCESS SYSTEM
Type of Device
SYSTEM, 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 Key13602094
MDR Text Key286150975
Report Number2134265-2022-02058
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/03/2024
Device Lot Number0027774632
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/21/2022
Initial Date FDA Received02/25/2022
Supplement Dates Manufacturer Received05/16/2022
Supplement Dates FDA Received05/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/04/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age78 YR
Patient SexFemale
Patient EthnicityHispanic
Patient RaceWhite
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