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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
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BOSTON SCIENTIFIC CORPORATION WATCHMAN ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL Back to Search Results
Model Number 10374
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/09/2021
Event Type  malfunction  
Event Description
It was reported there was a leak in the hemostatic valve.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a watchman laa closure device & delivery system (wds) were used.During the procedure the hemostatic valve could not be tightened enough.As a result of this there was blood leaking from the hemostatic valve while the devices were in the patient.There were no complications to the patient.The procedure was completed successfully with another was and the closure device was implanted in the laa of the patient.
 
Event Description
It was reported there was a leak in the hemostatic valve.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a watchman laa closure device & delivery system (wds) were used.During the procedure the hemostatic valve could not be tightened enough.As a result of this there was blood leaking from the hemostatic valve while the devices were in the patient.There were no complications to the patient.The procedure was completed successfully with another was and the closure device was implanted in the laa of the patient.
 
Manufacturer Narrative
Device/media analysis: the returned product consisted of a watchman access system (was) with the dilator in the sheath.The device was microscopically and visually examined.There was damage to the silicone valve.The device was functionally tested by attaching a syringe (filled with water), and positive/negative pressure was applied with the valve open and closed.There was a leak at the valve.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported leak.
 
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Brand Name
WATCHMAN 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 Key12341890
MDR Text Key267249857
Report Number2134265-2021-10511
Device Sequence Number1
Product Code NGV
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 10/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/19/2023
Device Model Number10374
Device Catalogue Number10374
Device Lot Number0026392385
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/30/2021
Date Manufacturer Received09/29/2021
Patient Sequence Number1
Patient Age56 YR
Patient Weight62
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