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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 Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2021
Event Type  Injury  
Event Description
It was reported that foreign material was present upon device deployment. A left atrial appendage (laa) closure procedure was being performed. A watchman truseal access system (was) was positioned and a watchman flx laa closure device & delivery system (wds) were used. After implantation of the device, upon removal of the was sheath, the physician noted thread-like material protruding from the distal end of the double curve sheath. The origin of the material was unknown but appeared to be part of the sheath. There were no patient complications.
 
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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 Key12436417
MDR Text Key270271905
Report Number2134265-2021-11338
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,Followup
Report Date 10/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM635TU70020
Device Catalogue NumberM635TU70020
Device Lot Number0027627832
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/08/2021
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: 09/07/2021 Patient Sequence Number: 1
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