MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA CP; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Model Number IMPELLA CP

Device Problem Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2022

Event Type  Injury  

Manufacturer Narrative

The impella device was not received from the customer, therefore, investigation of the device was not possible.Should the device or any new information be received, a supplemental mdr will be filed.Instructions for use for the related event are as follows: ¿evaluate the position of the impella catheter if the automated impella controller displays position alarms or if you observe lower than expected flows or signs of hemolysis.If the catheter does not appear to be correctly positioned, initiate steps to reposition it.¿ this report is being filed as part of a retrospective review of historical records.

Event Description

The user facility reported a 59-year-old female had a cp support and the patient experienced hemolysis and dark red urine.The impella cp was repositioned under echo.The patient was weaned off pressors and pulses improved.

• Brand Name: IMPELLA CP
• Type of Device: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill dr.; danvers MA 01923
• Manufacturer (Section G): ABIOMED, INC.; 22 cherry hill dr.; danvers MA 01923
• Manufacturer Contact: derek sammarco
• MDR Report Key: 18873547
• MDR Text Key: 337298988
• Report Number: 1220648-2024-07673
• Device Sequence Number: 1
• Product Code: OZD
• UDI-Device Identifier: 00813502011876
• UDI-Public: (01)00813502011876(10)2023221767(17)240430
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0045
• Device Lot Number: 2023221767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/11/2022
• Date Manufacturer Received: 12/11/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic