InjuryNQH
CARDIOMEMS ENDOSURE DELIVERY SYSTEM
Received Mar 12, 2007 · Event occurred Jan 10, 2007
Report 3004936110-2007-00002 · MDR key 827939
Device
Generic name
Intravascular Pressure Sensor
Manufacturer
CardiomemsModel number
*Catalog number
ADS-1001
Lot number
*
Product problems
- Source, detachment from
- Physical Resistance
Patient
67 YR
- Foreign body, removal of
Narrative
Description of Event or Problem
PATIENT HAD TORTUOUS ILIACS BILATERALLY. WHEN SENSOR DELIVERY SYSTEM WAS INSERTED, PHYSICIAN MET RESISTANCE. UPON REMOVAL, IT WAS FOUND THAT THE DILATOR TIP DETACHED FROM THE CATHETER BODY. A SNARE WAS USED TO RETRIEVE THE TIP. PATIENT DID NOT SUFFER ANY SUBSEQUENT INJURY.