FDA.reportPublic FDA data

MAUDE MDR 7356683

MDR report key
7356683
Report number
7356683
Event key
0
Event type
3
Date of event
2018-03-08
Date received
2018-03-21
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#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IMPELLA CPTEMPORARY CARDIAC SUPPORT BLOOD PUMPABIOMED, INC.PBL0048-0003.08140048-0003R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-03-2101. O

Event Narratives#

N

Patient 1

D

Patient 1

THE IMPELLA CP CATHETER FAILED WHILE IMPLANTED IN PATIENT. THE FLOW STARTED OUT BETWEEN 3.2 AND 3.4 AND THEN DROPPED TO 1.2. THE CATHETER WAS REMOVED, FLUSHED OUT, AND RE-IMPLANTED, BUT FLOW NEVER WENT ABOVE 1.2. IT WAS EVENTUALLY REPLACED WITH A 2.5 L PUMP THAT WAS NOT SUFFICIENT TO SUPPORT THE PATIENT. A RIGHT AXILLARY CUTDOWN WAS PERFORMED AND 5L PUMP WAS PLACE. ALTHOUGH UNRELATED TO THE PUMP FAILURE, THE PATIENT EXPIRED IN THE OPERATING ROOM. PER SITE REPORTER: (B)(4) REPS WERE PRESENT DURING SURGERY. THE DEVICE WILL BE RETURNED FOR FAILURE ANALYSIS.