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

Lot Number 28122910

Device Problem Break (1069)

Patient Problems Apnea (1720); Diminished Pulse Pressure (2606); Foreign Body In Patient (2687)

Event Date 01/04/2022

Event Type  Death  

Event Description

Patient required thrombectomy under interventional radiology.Large segment of the sheath broke off while inside the patient.The retained object then required removal with a separate sheath.After this procedure the patient lost her pulse and was not breathing.Fda safety report id# (b)(4).

• Brand Name: WATCHMAN TRUSEAL
• Type of Device: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 13223977
• MDR Text Key: 283666476
• Report Number: MW5106561
• 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: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 28122910
• Was Device Available for Evaluation?: Yes
• 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: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White