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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
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BOSTON SCIENTIFIC CORPORATION WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL Back to Search Results
Model Number 10390
Device Problems Difficult to Flush (1251); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2024
Event Type  malfunction  
Event Description
It was reported that an aborted procedure occurred.A 20mm watchman flx left atrial appendage (laa) closure device (lot # 31451045) was opened for preparation for a laa closure procedure.While flushing the device, a bubble was noticed in the plastic tubing near the hub.There appeared to be a small hole in the tubing upon further examination.The 20mm watchman flx laa closure device (lot # 31451045) was not used for the procedure.A second 20mm watchman flx laa closure device (lot # 31341672) was successfully prepared and loaded into the sheath.However, the second 20mm watchman flx laa closure device (lot # 31341672) could not be successfully deployed due to the coaxiality experienced.Thus, the second 20mm watchman flx laa closure device (lot # 31341672) did not meet release criteria as it could not be positioned deep enough in the laa.One full recapture of the 20mm closure device (lot # 31341672) was performed, and the procedure was aborted while the patient was under general anesthesia.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: returned device consisted of a watchman flx delivery system with the implant in the sheath.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 could not be flushed properly.The device was not able to backflush, and air could not be purged from the device, so the valve was removed and microscopically examined.Microscopic examination revealed the silicone valve was damaged.There was tip damage as the tri-cuts were flared and there were abrasions on the inside of the sheath tip.Inspection of the device found numerous kinks in the sheath and a small hole in the sheath 1cm distal of the white snapping feature.Product analysis confirmed the reported event, as the silicone valve was damaged, causing difficulty with the flushing of the device.Product analysis also confirmed the event of damage as the sheath was damaged.
 
Event Description
It was reported that an aborted procedure occurred.A 20mm watchman flx left atrial appendage (laa) closure device (lot # 31451045) was opened for preparation for a laa closure procedure.While flushing the device, a bubble was noticed in the plastic tubing near the hub.There appeared to be a small hole in the tubing upon further examination.The 20mm watchman flx laa closure device (lot # 31451045) was not used for the procedure.A second 20mm watchman flx laa closure device (lot # 31341672) was successfully prepared and loaded into the sheath.However, the second 20mm watchman flx laa closure device (lot # 31341672) could not be successfully deployed due to the coaxiality experienced.Thus, the second 20mm watchman flx laa closure device (lot # 31341672) did not meet release criteria as it could not be positioned deep enough in the laa.One full recapture of the 20mm closure device (lot # 31341672) was performed, and the procedure was aborted while the patient was under general anesthesia.No patient complications were reported.
 
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Brand Name
WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM
Type of Device
SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18848218
MDR Text Key337621552
Report Number2124215-2024-11368
Device Sequence Number1
Product Code NGV
UDI-Device Identifier08714729860488
UDI-Public08714729860488
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/06/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10390
Device Catalogue Number10390
Device Lot Number0031451045
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/22/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/18/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age77 YR
Patient SexMale
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