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); Air/Gas in Device (4062)

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

Event Date 02/15/2024

Event Type  malfunction  

Event Description

It was reported that air within the device occurred.A left atrial appendage (laa) closure procedure was performed using a 31mm watchman flx laa closure device with delivery system (wds) and watchman access system (was).During flushing of the wds, air was repeatedly visualized within the device.After tightening the device, air was cleared.The wds was then inserted into the was and following cessation of flushing a bubble of air developed within the wds.The wds was removed, and the procedure was completed with a new wds.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: the returned device consisted of a watchman flx delivery system (wds) with the implant in the sheath.The device was visually and microscopically inspected.Numerous kinks were identified along the length of the sheath.Functional testing was performed by applying positive and negative pressure with the hemostatic valve open and closed.The device was not able to backflush, and air was unable to be purged from the device.The hemostatic valve was removed, and microscopic analysis identified the silicone valve was damaged.Product analysis confirmed the reported event of device difficult to flush.

Event Description

It was reported that air within the device occurred.A left atrial appendage (laa) closure procedure was performed using a 31mm watchman flx laa closure device with delivery system (wds) and watchman access system (was).During flushing of the wds, air was repeatedly visualized within the device.After tightening the device, air was cleared.The wds was then inserted into the was and following cessation of flushing a bubble of air developed within the wds.The wds was removed, and the procedure was completed with a new wds.No patient complications were reported.

• 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 Key: 18841880
• MDR Text Key: 337620585
• Report Number: 2124215-2024-12892
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 08714729860518
• UDI-Public: 08714729860518
• 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
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10390
• Device Catalogue Number: 10390
• Device Lot Number: 0032887497
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Female