MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number 10390

Device Problems Difficult to Flush (1251); Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2022

Event Type  malfunction  

Event Description

It was reported that there was air seen within the watchman flx laa closure device & delivery system.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 35mm watchman flx laa closure device & delivery system (wds) were used.The physician was prepping the 35mm wds and noted that there was a lot of air present while flushing the device.After additional checks and more flushing the wds was clear of any air.The procedure was continued with the physician positioning the was into the laa of the patient.The wds was then inserted into the was when a large air bubble was seen in the wds.The procedure was paused and the physician used a syringe to create negative suction on the wds while it was removed from the was.The wds was removed from the patient and a new wds was prepared.The physician had similar air issues noted during preparation of the new wds so a third wds was prepared.The third wds was used to successfully complete the procedure with a closure device implanted in the laa of the patient.Post procedure the patient showed no signs of any consequences as a result of this event.

Manufacturer Narrative

Device analysis: the returned product consisted of a watchman flx delivery system with the implant in the sheath, and blood in the hub of the device.The implant, core wire, tip, sheath, and hub/valve were microscopically and visually examined.Inspection revealed that there were numerous kinks throughout the sheath and there was tip damage as the tri-cuts were flared and there were abrasions on the inside of the sheath at the tip.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.The silicone valve was found to be damaged.There was no other damage or defect found on the remainder of the device.Product analysis confirmed the reported event, as the silicone valve was damaged, causing difficulty with the flushing of the device.

Event Description

It was reported that there was air seen within the watchman flx laa closure device & delivery system.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 35mm watchman flx laa closure device & delivery system (wds) were used.The physician was prepping the 35mm wds and noted that there was a lot of air present while flushing the device.After additional checks and more flushing the wds was clear of any air.The procedure was continued with the physician positioning the was into the laa of the patient.The wds was then inserted into the was when a large air bubble was seen in the wds.The procedure was paused and the physician used a syringe to create negative suction on the wds while it was removed from the was.The wds was removed from the patient and a new wds was prepared.The physician had similar air issues noted during preparation of the new wds so a third wds was prepared.The third wds was used to successfully complete the procedure with a closure device implanted in the laa of the patient.Post procedure the patient showed no signs of any consequences as a result of this event.

• 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 Key: 15421001
• MDR Text Key: 305542044
• Report Number: 2124215-2022-35670
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 08714729860525
• UDI-Public: 08714729860525
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10390
• Device Catalogue Number: 10390
• Device Lot Number: 0028887882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Race: White