N
Patient 1
DEVICE DISCARDED BY CUSTOMER. THE IMPELLA CP OPTICAL PUMP WAS DISCARDED BY THE CUSTOMER THEREFORE A FAILURE ANALYSIS INVESTIGATION CANNOT BE COMPLETED.
MAUDE MDR 9887049
- MDR report key
- 9887049
- Report number
- 1220648-2020-00395
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-06
- Date received
- 2020-03-26
- 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 | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | IMPELLA CP OPTICAL PUMP | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP, | ABIOMED, INC. | OZD | IMPELLA CP PUMP 371 SET, US | 0048-0024 | 1460151 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-26 | 0 | 1. R |
Event Narratives#
D
Patient 1
THE COMPLAINANT REPORTED A (B)(6) WHITE MALE PATIENT HAD IMPELLA CP OPTICAL PUMP INSERTED IN THE LEFT FEMORAL ARTERY (LFA) FOR ACUTE MYOCARDIAL INFARCTION (AMI)/ CARDIOGENIC SHOCK (CGS). UPON REMOVAL OF THE PEEL-AWAY SHEATH POST PROCEDURE, IT WAS NOTED THAT THE LFA SITE WAS BLEEDING AND DESPITE ATTEMPTS TO ANGLE MATCH THE CATHETER AND "SNUG" THE PERCLOSE SUTURES AROUND THE SHEATH THE SITE CONTINUED TO BLEED. THE PHYSICIAN DECIDED TO REMOVE THE PUMP AND OBTAIN HEMOSTASIS ON THE LFA SITE WITH PERCLOSE. A SECOND PUMP WAS PLACED DUE TO HEMODYNAMIC INSTABILITY. A CENTRAL LINE WAS PLACED FOR BLOOD/FLUIDS TO BE ADMINISTERED. THE PATIENT WAS INITIALLY GIVEN TWO (2) UNITS OF WHOLE BLOOD AND THREE (3) MORE UNITS OF WHOLE BLOOD WAS GIVING DURING THE CASE.