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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 Positioning Failure (1158); Difficult to Remove (1528); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/04/2022
Event Type  malfunction  
Event Description
It was reported that difficulty recapturing the device occurred.A left atrial appendage (laa) closure procedure was performed using a 35mm watchman flx laa closure device with delivery system (wds).The closure device was unable to achieve optimal positioning and a partial recapture was attempted.The laa morphology was highly pectinated and recapturing the closure device was difficult.A full recapture was eventually successful and after repositioning for deployment the closure device was unable to be unsheathed.The closure device was removed from the patient.Upon removal from the patient, it was observed the implant frame was twisted.The laa closure procedure was completed with a new 35mm watchman flx closure device.No complications were reported.
 
Manufacturer Narrative
Device analysis: the returned product consisted of a 35mm watchman flx delivery system (wds) with the implant deployed.The implant, core wire, tip, sheath, and hub were microscopically and visually analyzed.Multiple kinks were noted in the sheath.Inspection of the tip found flared tri-cuts and abrasions on the inside of the sheath tip.The closure device anchors were hooked onto the struts.Product analysis could not confirm the reported events of difficulty recapturing and deploying as clinical circumstances could not be replicated.Product analysis confirmed the reported event of struts twisted, as the closure device anchors were hooked onto the struts.
 
Event Description
It was reported that difficulty recapturing the device occurred.A left atrial appendage (laa) closure procedure was performed using a 35mm watchman flx laa closure device with delivery system (wds).The closure device was unable to achieve optimal positioning and a partial recapture was attempted.The laa morphology was highly pectinated and recapturing the closure device was difficult.A full recapture was eventually successful and after repositioning for deployment the closure device was unable to be unsheathed.The closure device was removed from the patient.Upon removal from the patient, it was observed the implant frame was twisted.The laa closure procedure was completed with a new 35mm watchman flx closure device.No 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
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 Key15601110
MDR Text Key301776075
Report Number2124215-2022-40082
Device Sequence Number1
Product Code NGV
UDI-Device Identifier08714729860525
UDI-Public08714729860525
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,Followup
Report Date 10/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/25/2024
Device Model Number10390
Device Catalogue Number10390
Device Lot Number0027209376
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/26/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age76 YR
Patient SexMale
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