CARDIOMEMS ENDOSURE DELIVERY SYSTEM
Received Aug 15, 2007 · Event occurred Aug 9, 2007
Report 3004936110-2007-00012 · MDR key 903482
Device
Generic name
Intravascular Pressure Sensor
Manufacturer
Cardiomems, Inc.Model number
*Catalog number
S2-2080
Lot number
*
Product problems
- Unknown (for use when the device problem is not known)
Patient
87 YR
- Transfusion of blood products
- Therapy/non-surgical treatment, additional
- Blood pressure, decreased
- Blood Loss
Narrative
Description of Event or Problem
PATIENT HAS HEAVILY CALCIFIED ILIAC ARTERIES. SENSOR WAS INTRODUCED THROUGH A 14F SHEATH VIA STIFF GUIDEWIRE. A PIGTAIL CATHETER WAS INTRODUCED BESIDE THE SENSOR DELIVERY SYSTEM. THERE WAS VISIBLE BLOOD COMING FROM THE SHEATH AND THERE WERE ATTEMPTS MADE TO CONTAIN AND STOP THE BLOOD LOSS. BLEEDING CONTINUED THROUGHOUT THE PROCEDURE AND PATIENT'S BLOOD PRESSURE DROPPED. THE PT HAD TO BE PUT ON CELL SAVER AND ULTIMATELY WAS GIVEN BLOOD. THE SENSOR DELIVERY WAS STILL SUCCESSFUL AND PATIENT WAS STABLE AT THE END OF THE PROCEDURE.