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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 0024192194
Device Problems Device Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/07/2020
Event Type  malfunction  
Manufacturer Narrative
Event date is approximate since unknown.
 
Event Description
It was reported that there was tip damage.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was used.During the procedure, the access system was removed from the patient and it was noted that there was tip damage.There were no complications that occurred during the procedure and no harm was done to the patient.The patient was fine following this event.
 
Manufacturer Narrative
Lot number updated from unknown to 0024192194.Expiration date update from unknown to 07/30/2022.Unique identifier updated from unknown to (b)(4).Device manufactured date updated from unknown to 07/31/2019.
 
Event Description
It was reported that there was tip damage.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was used.During the procedure, the access system was removed from the patient and it was noted that there was tip damage.There were no complications that occurred during the procedure and no harm was done to the patient.The patient was fine following this event.It was further reported that the was was introduced into the body and positioned into the laa.Then the 27mm watchman laa closure device was introduced into the sheath and deployed.The closure device did not meet release criteria so it was fully recaptured and removed from the patient.After full recapture, it appeared that there was a thrombus on the end of the was.The physician removed the was from the body and the inspection of it showed there was no thrombus, but a wire that was exposed from the inside of the sheath.A new was was inserted into the laa and a 24mm watchman flx closure device was used to successfully complete the procedure.
 
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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 Key10334111
MDR Text Key200661759
Report Number2134265-2020-09882
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/30/2022
Device Lot Number0024192194
Was Device Available for Evaluation? No
Date Manufacturer Received08/13/2020
Patient Sequence Number1
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