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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 0024692376
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis (2100)
Event Date 02/07/2020
Event Type  Injury  
Event Description
It was reported that a thrombus occurred.A left atrial appendage (laa) closure procedure was being performed.Pre-procedure transesophageal echocardiogram (tee) noted haziness in the laa, but no thrombus was observed.A watchman truseal access system (was) was inserted into the patient and another tee was performed upon approaching into the left atrium.At this time, a thrombus was seen in the laa.The case was aborted and all devices were removed.No thrombus was noted to the device itself.No further complications were reported.
 
Manufacturer Narrative
Returned product consisted of a watchman truseal system with the dilator snapped into the hub.Analysis of the tip, sheath, and hub/valve included microscopic and visual inspection.Inspection found no damage or defect to the device.The medical review for this device indicated that thrombosis was anticipated.
 
Event Description
It was reported that a thrombus occurred.A left atrial appendage (laa) closure procedure was being performed.Pre-procedure transesophageal echocardiogram (tee) noted haziness in the laa, but no thrombus was observed.A watchman truseal access system (was) was inserted into the patient and another tee was performed upon approaching into the left atrium.At this time, a thrombus was seen in the laa.The case was aborted and all devices were removed.No thrombus was noted to the device itself.No further complications were reported.
 
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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
MDR Report Key9785263
MDR Text Key181972567
Report Number2134265-2020-02390
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
P130013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 05/11/2020
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 Date10/30/2022
Device Lot Number0024692376
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2020
Initial Date Manufacturer Received 02/07/2020
Initial Date FDA Received03/04/2020
Supplement Dates Manufacturer Received04/16/2020
Supplement Dates FDA Received05/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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