inforMED
InjuryNGV

WATCHMAN

Received Oct 10, 2019 · Event occurred Sep 12, 2019

Report MW5090346 · MDR key 9179867

Device

Generic name

System, Appendage Closure, Left Atrial

Catalog number

M635WU33060

Lot number

23804653

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

73 YR

  • Pseudoaneurysm
  • Pseudoaneurysm

Narrative

Description of Event or Problem

WATCHMAN DEVICE IMPLANTATION FOR CHRONIC AFIB. PT ON CHRONIC ANTI-COAGULATION. ON (B)(6) 2019 RIGHT COMMON FEMORAL PSEUDOANEURYSM-REPAIRED SURGICAL DRAIN IN PLACE FOR 1 WEEK. DISCHARGED HOME WITH OPD F/U IN STABLE CONDITION.