FDA.reportPublic FDA data

MAUDE MDR 9654401

MDR report key
9654401
Report number
1220648-2020-00329
Event key
0
Event type
3
Date of event
2020-01-06
Date received
2020-01-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. RALPH BARISANO
Address
22 CHERRY HILL DR. DANVERS MA 01923 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IMPELLA RPTEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMPABIOMED, INC.PYXIMPELLA RP US PUMP SET0043341429348R R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-3101. R

Event Narratives#

N

Patient 1

THE IMPELLA RP WAS RETURNED AND AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, A SUPPLEMENTAL MDR WILL BE FILED.

D

Patient 1

A (B)(6) WHITE MALE PRESENTED POST CARDIOTOMY CARDIOGENIC SHOCK WHILE ON LEFT VENTRICLE HEMODYNAMIC SUPPORT WITH AN IMPELLA CP. AN ATTEMPT TO WEAN AND REMOVE THE CP WAS UNSUCCESSFUL AS PATIENT'S CONDITION WOULD INTOLERANT. A TRANSTHORACIC ECHOCARDIOGRAM WAS COMPLETED AND THE PATIENT'S RIGHT VENTRICLE WAS FOUND DILATED. THEREFORE, THE DECISION WAS MADE TO INSERT AN IMPELLA RP TO HELP IMPROVE THE PATIENT'S CONDITION ENOUGH TO REMOVE THE CP. THE PHYSICIAN CHOSE TO INSERT THE RP IN THE LEFT FEMORAL VEIN DUE TO INSERTION OF CP AND RIGHT COMMON FEMORAL VEIN INACCESSIBLE UNDER ULTRASOUND GUIDANCE. DESPITE RECOMMENDATIONS IN THE IMPELLA INSTRUCTIONS FOR USE, AND ADVISEMENT OF CLINICAL FIELD REPRESENTATIVE, THE PHYSICIAN INSERTED THE IMPELLA RP INTO THE PATIENTS LEFT FEMORAL VEIN. DURING INSERTION, THE DEVICE FAILED TO ACCESS THE PULMONARY ARTERY. THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE BY PULLING THE GUIDE WIRE, PRIOR TO PULLING THE PUMP. THEREAFTER, THE PUMP SEPARATED IN THE PATIENT'S INFERIOR VENA CAVA, AT THE DISTAL BALL WHICH CONNECTS THE DEVICE'S OUTLET CAGE TO THE PIGTAIL. THE RP WAS REMOVED AND A SNARE WAS UTILIZED TO REMOVE THE DETACHED COMPONENT.