MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN FLX 24 MM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number FLX

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 10/30/2023

Event Type  Death  

Event Description

The patient underwent a watchman placement procedure.The patient sustained an acute perforation while deploying the watchman flx 20 mm with device.The watchman and the sheath were pulled out and the patient experienced a hemorrhagic episode and later expired.

• Brand Name: WATCHMAN FLX 24 MM
• Type of Device: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 18181886
• MDR Text Key: 328784768
• Report Number: MW5148332
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FLX
• Device Lot Number: 31681036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 87 KG
• Patient Ethnicity: Hispanic
• Patient Race: White