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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 Hemorrhage/Bleeding (1888)
Event Date 04/21/2022
Event Type  Injury  
Event Description
It was reported that a device leak occurred.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.The physician positioned the was in the laa of the patient.While the access system was in the patient the hemostatic valve leaked about 50ml of blood.The physician removed this device from the patient and used a new was to complete the procedure.The procedure was completed with a closure device implanted in the laa of the patient.There were no patient complications that were reported to have occurred.
 
Manufacturer Narrative
Device analysis: the returned product consisted of a watchman access system (was) with the dilator in the sheath and blood in the device.Analysis of the dilator, hub/valve, tip and sheath included microscopic and visual inspection.Functional testing was completed by attaching a syringe filled with water, and positive/negative pressure was applied with the valve open and closed.The device was not able to be flushed properly.The device was not able to backflush, and air was not able to be purged from the device.Water leaked from the hub with the dilator inserted.The dilator was removed, and the hemostatic valve was tightened with no water leaking from the valve.The valve was removed and microscopically examined.The valve was found to have no damage.The threads of the hub and sheath were microscopically inspected and found damage to the threads on the sheath.There was no other damage or defect found on the remainder of the device.The reported hemostatic valve leak was confirmed.
 
Event Description
It was reported that a device leak occurred.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.The physician positioned the was in the laa of the patient.While the access system was in the patient the hemostatic valve leaked about 50ml of blood.The physician removed this device from the patient and used a new was to complete the procedure.The procedure was completed with a closure device implanted in the laa of the patient.There were no patient complications that were reported to have occurred.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key14569451
MDR Text Key293140876
Report Number2134265-2022-06186
Device Sequence Number1
Product Code NGV
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number10374
Device Catalogue Number10374
Device Lot Number0027352955
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age75 YR
Patient SexFemale
Patient Weight56 KG
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