FDA.reportPublic FDA data

MAUDE MDR 514712

MDR report key
514712
Report number
9610614-2004-00003
Event key
0
Event type
3
Date of event
2004-02-02
Date received
2004-02-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JOHN TARTAL
Address
2225 NORTHWEST PARKWAY MARIETTA GA 30067 US
Phone
770-770-7709
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ERBOKRYO CA UNITCRYOSURGICAL SYSTEMERBE ELEKTROMEDIZIN GMBHGEHERBOKRYO CA10448-004NANYR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12004-02-2701. D

Event Narratives#

D

Patient 1

DURING A PALLIATIVE PROCEDURE WITH THE CRYOSURGICAL SYSTEM TO REMOVE NECROTIC TUMOR TISSUE, MASSIVE BLEEDING OCCURRED. THE SETTINGS WERE REPORTED AS BEING STANDARD. THE PT WAS IDENTIFIED AS HAVING EXTREME END-STAGE TUMOR DISEASE OF THE LUNGS AND BRONCHIAL TREE. IT APPEARS THAT THE NECROSED TUMOR WAS INVASIVE IN THE WALL ADJACENT TO THE ARTERY. UPON REMOVING THE TUMOR TISSUE, THE WALL WAS UNABLE TO STAY INTACT WHICH RESULTED IN THE BLEEDING. MEDICAL PERSONNEL ATTEMPTED TO INTUBATE/SUCTION BUT WERE UNABLE TO MAINTAIN VITAL SIGNS (NOTE: PT WAS ON A RESPIRATOR AND DOCUMENTED AS DO NOT RESUSCITATE). THE PT EXPIRED.