FDA.reportPublic FDA data

MAUDE MDR 6297551

MDR report key
6297551
Report number
MW5067613
Event key
0
Event type
3
Date of event
2017-01-24
Date received
2017-01-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ABIOMED IMPELLA CP PERCUTANIOUS LVADABIOMED IMPELLA CP PERCUTANIOUS LVADABIOMEDPBLIMPELLA CP0048-0003I Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-01-3101. O

Event Narratives#

D

Patient 1

IMPELLA CP DID NOT GO ABOUT 0.9 L/MIN OR FLOW AFTER INSERTION INTO THE PATIENT. SUCTION ALARMS ALSO STARTED TO SHOW. IMPELLA WAS REPOSITIONED SEVERAL TIMES WITHOUT RESOLUTION OF THE PROBLEM. IMPELLA PUMP PULLED OUT AND TESTED IN A BASIN FILLED WITH HEPARINIZED SALINE. SUCTION ALARMS CONTINUED TO SHOW DURING TESTING. GROSS EXAMINATION OF THE PUMP DID NOT REVEAL ANY CLOTS CAUGHT IN THE PUMP CAGE. NEW IMPELLA CATHETER WAS PREPPED AND INSERTED WITH NO PROBLEMS ENCOUNTERED. DIAGNOSIS OR REASON FOR USE: CARDIOGENIC SHOCK.