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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 12/07/2021
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 approximately 100 to 200 ml of blood loss occurring during the procedure.An 8f sheath was also in the patient at the time of the event.The pigtail catheter was pre-sheathed with the 8f short sheath.When the inner core of the sheath was withdrawn and the pigtail catheter was inserted, the hemostatic valve was found screwed to the head, but the blood loss could not be mitigated.The was was however able to be tightened when the inner core of the sheath had yet to be withdrawn.The physician attempted to stop the bleeding by retwisting the hemostatic valve several times, but was unsuccessful.The procedure was completed with a new was and 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 able to be flushed properly.The device was able to backflush, and air was able to be purged from the device.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.There was no damage or defect found on the remainder of the device.The reported hemostatic valve leak could not be 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 approximately 100 to 200 ml of blood loss occurring during the procedure.An 8f sheath was also in the patient at the time of the event.The pigtail catheter was pre-sheathed with the 8f short sheath.When the inner core of the sheath was withdrawn and the pigtail catheter was inserted, the hemostatic valve was found screwed to the head, but the blood loss could not be mitigated.The was was however able to be tightened when the inner core of the sheath had yet to be withdrawn.The physician attempted to stop the bleeding by retwisting the hemostatic valve several times, but was unsuccessful.The procedure was completed with a new was and 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
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13020187
MDR Text Key282386244
Report Number2134265-2021-15817
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 01/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2021
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 Number0027352957
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/24/2022
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 Age71 YR
Patient SexMale
Patient Weight70 KG
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