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

Device Problem Positioning Failure (1158)

Patient Problem Cardiac Perforation (2513)

Event Date 05/30/2023

Event Type  Injury  

Manufacturer Narrative

B3: the event date was not reported, the aware date was used as an estimate.

Event Description

The following event originated from social media, and therefore despite good faith efforts the information is often incomplete.Additionally, due to the limited information received through good faith efforts, this event may represent a duplicate of an event which was already known to boston scientific.It was reported that the device failed to deploy, and cardiac perforation occurred.A left atrial appendage (laa) closure procedure was performed, and a watchman flx laa closure device was attempted to be implanted.The device failed to deploy and upon retraction, the closure device perforated the patient's heart.The patient spent a week in the intensive care unit 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; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17099363
• MDR Text Key: 316888295
• Report Number: 2124215-2023-27876
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male