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 Problem Difficult to Flush (1251)

Patient Problem Air Embolism (1697)

Event Date 03/25/2024

Event Type  Injury  

Event Description

It was reported an air embolism occurred.A left atrial appendage (laa) closure procedure was performed using a 27mm watchman flx laa closure device with delivery system (wds) and watchman truseal access system (was).During preparation of the wds, difficulty was encountered flushing air from the device but was ultimately successful.The wds was positioned and during deployment of the closure device air was visualized in the laa.The air was aspirated and the wds and was were removed from the patient anatomy.The procedure was completed with a new wds and was.A post-procedure neurological exam was performed, and the patient was doing well.No patient complications were reported.

Event Description

It was reported an air embolism occurred.A left atrial appendage (laa) closure procedure was performed using a 27mm watchman flx laa closure device with delivery system (wds) and watchman truseal access system (was).During preparation of the wds, difficulty was encountered flushing air from the device but was ultimately successful.The wds was positioned and during deployment of the closure device air was visualized in the laa.The air was aspirated and the wds and was were removed from the patient anatomy.The procedure was completed with a new wds and was.A post-procedure neurological exam was performed, and the patient was doing well.No patient complications were reported.It was further reported the patient fully recovered and was discharged two (2) days post index procedure.

Manufacturer Narrative

A2 age at time of event updated b5 describe event or problem updated b7 other relevant history updated.

• 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: 19005684
• MDR Text Key: 338929708
• Report Number: 2124215-2024-18545
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• 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: 0032270106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR