DeathNGV

BOSTON SCIENTIFIC WATCMAN FLX

Received Apr 11, 2023 · Event occurred Apr 4, 2023

Report MW5116547 · MDR key 16726476

Device

Generic name

System, Appendage Closure, Left Atrial

Manufacturer

Boston Scientific Corp., Marina Bay Cust Fulfillment Center

Model number

WATCHMAN FLX 24MM

Lot number

29618978

Product problems

Activation Problem

Patient

78 YR · Female

Pericardial Effusion
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Pericardial Effusion
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

Narrative

Description of Event or Problem

DEVICE WAS ENVELOPED (NOT FULLY DEPLOYED) AND IT WAS DECIDED TO RE-CAPTURE DEVICE AND REPOSITION. ECHO REVEALED A PERICARDIAL EFFUSION RESULTING IN PROCEDURE SWITCHING TO AN 'OPEN' PROCEDURE. PATIENT CODED DURING PROCEDURE AND WAS NOT SUCCESSFULLY RESUSCITATED.