FDA.reportPublic FDA data

MAUDE MDR 9792497

MDR report key
9792497
Report number
9792497
Event key
0
Event type
3
Date of event
2019-11-25
Date received
2020-03-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IMPELLA CP SETTEMPORARY CARDIAC SUPPORT BLOOD PUMPABIOMED, INC.PBL0048-0003* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-050

Event Narratives#

D

Patient 1

0.018 IMPELLA WIRE UNWOUND AND FRACTURED IN THE PATIENT. THE ENTIRE WIRE WAS RETRIEVED AND THERE WAS NO EVIDENCE OF ANY RETAINED WIRE IN THE PATIENT. A NEW WIRE WAS OBTAINED FROM ANOTHER KIT AND THE CASE CONTINUED. IMPELLA WIRE ADVANCED THROUGH PIGTAIL CATHETER. PIGTAIL REMOVED. IMPELLA CATHETER ADVANCED OVER THE WIRE TO LV, WIRE REMOVED. WIRE FRAGMENT NOTICED ON X-RAY IN IMPELLA. IMPELLA CATHETER AND WIRE REMOVED. 6FR. PIGTAIL ADVANCED OVER THE WIRE TO LV, WIRE REMOVED. IMPELLA WIRE ADVANCED THROUGH PIGTAIL CATHETER. PIGTAIL REMOVED. IMPELLA CATHETER ADVANCED OVER THE WIRE TO LV, WIRE REMOVED.