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

Model Number 10372

Device Problems Difficult to Flush (1251); Material Integrity Problem (2978)

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

Event Date 06/28/2023

Event Type  malfunction  

Event Description

It was reported that device damage occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system was positioned and a 30mm watchman closure device and delivery system (wds) was advanced.The wds was deployed, however release criteria were not met and the device was fully recaptured.It was then observed that the marker band at the distal end of the wds was damaged and noted that the air tightness of the wds was faulty during flushing.The wds was removed and exchanged for a second 30mm wds to complete the procedure.No patient complications occurred.

Event Description

It was reported that device damage occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system was positioned and a 30mm watchman closure device and delivery system (wds) was advanced.The wds was deployed, however release criteria were not met and the device was fully recaptured.It was then observed that the marker band at the distal end of the wds was damaged and the air tightness of the wds was faulty during flushing.The wds was removed and exchanged for a second 30mm wds to complete the procedure.No patient complications occurred.

Manufacturer Narrative

Device evaluated by mfr.: the returned product consisted of a watchman delivery system with the implant in the sheath and blood in the device.The implant, core wire, tip, sheath, and hub/valve were microscopically and visually examined.Inspection revealed numerous kinks in the sheath.There was tip damage as there were abrasions on the inside of the sheath and tip, the tri-cuts were flared, and the distal marker band was kinked.There was implant anchor damage.The anchor and tip damage is consistent with deploying and recapturing the implant.Functional testing was completed by attaching a syringe filled with water while positive and 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 purged from the device.The valve was removed and microscopically examined.The silicone valve was found to be damaged.Product analysis confirmed the reported event of difficulty flushing as the device was difficult to flush and damage to the valve was observed during analysis, which could have contributed to difficulty with the flushing of the device.Product analysis confirmed the reported event of marker band damage as the distal marker band was kinked.

• Brand Name: WATCHMAN LAA CLOSURE DEVICE & 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 Key: 17332926
• MDR Text Key: 319190271
• Report Number: 2124215-2023-35764
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10372
• Device Catalogue Number: 10372
• Device Lot Number: 0029760814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 60 KG