inforMED
MalfunctionNQH

ENDOSURE AAA PRESSURE SENSOR/DELIVERY SYSTEM

Received Nov 28, 2006 · Event occurred Nov 2, 2006

Report 3004936110-2006-00005 · MDR key 791829

Device

Generic name

Intrasac Pressure Sensor/delivery Cath

Manufacturer

Cardiomems, Inc.

Model number

NA

Catalog number

*

Lot number

NA

Product problems

  • Detachment Of Device Component
  • Replace
  • Use of Device Problem
  • Device, removal of (non-implant)

Patient

76 YR

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

THE GUIDEWIRE WAS INADVERTANTLY REMOVED DURING SENSOR DELIVERY, CAUSING MOVEMENT OF THE DELIVERY SYSTEM WITHOUT GUIDEWIRE SUPPORT. WHEN THE DELIVERY CATHETER WAS REMOVED, THE PHYSICIAN NOTED THAT THE NOSE CONE WAS DETACHED. THE NOSE CONE WAS REMOVED AND A SECOND DEVICE WAS INSERTED WITHOUT DIFFICULTY. THE PT WAS DISCHARGED WITHOUT FURTHER INCIDENT.