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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 04/13/2022
Event Type  Injury  
Event Description
It was reported that a hemostasis valve leak occurred.A left atrial appendage (laa) closure procedure was being performed.A double curve watchman access system (was) was positioned and the hemostasis valve could not be tightened, resulting in 5 ml of blood loss and 20ml of contrast agent leakage during the procedure.An 8f short sheath was also in the patient at the time of the event.The 8f short sheath was connected to the tip of the pigtail catheter into the was.The hemostasis valve could not be tightened on the 8f short sheath.The was was exchanged with a new was using the same 8f short sheath, and the procedure was successfully completed.No further patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: 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.The dilator was removed, and the hemostatic valve was tightened, and water leaked 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.A kink in the sheath was caused during analysis.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 hemostasis valve leak occurred.A left atrial appendage (laa) closure procedure was being performed.A double curve watchman access system (was) was positioned and the hemostasis valve could not be tightened, resulting in 5 ml of blood loss and 20ml of contrast agent leakage during the procedure.An 8f short sheath was also in the patient at the time of the event.The 8f short sheath was connected to the tip of the pigtail catheter into the was.The hemostasis valve could not be tightened on the 8f short sheath.The was was exchanged with a new was using the same 8f short sheath, and the procedure was successfully completed.No further patient complications were reported.
 
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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 Key14194491
MDR Text Key289981718
Report Number2134265-2022-04683
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 08/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10374
Device Catalogue Number10374
Device Lot Number0027600505
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 Manufactured07/02/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age72 YR
Patient SexMale
Patient Weight70 KG
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