IMPELLA CP SET 01-00813502010879101357925

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-28 for IMPELLA CP SET 01-00813502010879101357925 manufactured by Abiomed, Inc..

Event Text Entries

[134709014] A (b)(6) year old male presenting with hypotension (63/41), dizziness requiring pressor support. Ti 23. 7 increasing to 37. 5, severe cardiomyopathy with ef 20-25%. Taken to cl for nstemi and treatment of cardiogenic shock. Found to have critical left main stenosis with severe left circumflex obtuse marginal branch stenosis and severe to critical rca stenosis. An impella was placed. The sheath was exchanged for a 14-french sheath and then was able to cross the impella device across the aortic valve under fluoroscopic guidance and confirmed adequate placement. Peel -away sheath was then taken and removed with insertion sheath. I then put in place at the arteriotomy site the impella insertion sheath. Maintain hemostasis. However, the impella device simply would not turn on despite all adequate checks. Multiple attempts then were made at maintaining arteriotomy site access including floating a 9-french, as well as a 10-french sheath over the insertion sheath via the impella catheter itself. However , i could not get access into the arteriotomy site. In light of this , i then maintained that the impella was pulled back into the level of the descending aorta. The patient was hemodynamically stable. However, given the fact that we could not maintain access site if it was removed, the decision was to leave the impella in the body in the level of the descending aorta, maintaining hemostasis with the impella insertion sheath in place, maintaining hemostasis at the level of the arteriotomy site. Patient was transferred to a facility with critical pci/cabg capability. They were unable to get the impella to work, so the impella was removed and patient placed on iabp (occurred at another facility). On inspection, it was noted that the cheater had not been completely removed from the device before insertion which shut down the impella. No apparent patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5083437
MDR Report Key8286331
Date Received2019-01-28
Date of Report2019-01-25
Date of Event2019-01-04
Date Added to Maude2019-01-29
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameIMPELLA CP SET
Generic NameTEMPORARY CARDIAC SUPPORT BLOOD PUMP
Product CodePBL
Date Received2019-01-28
Model Number01-00813502010879101357925
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerABIOMED, INC.
Manufacturer AddressDANVERS MA 01923 US 01923


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-01-28

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