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

Model Number	IMPELLA RP
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation into the high purge pressure issue has been completed.The impella rp was not received from the customer and therefore, an evaluation of the device was not possible.The clinical details provided were insufficient to determine the root cause.Additionally, neither the product nor data logs were returned for analysis.The cause of the high purge pressure was not determined since neither the product, nor the data logs were returned.Impella rp instructions for use for the related event are as follows: impella rp with smart assist system.Section: using the automated impella controller with the impella rp with smart assist system catheter as noted in the impella ifu ¿unresolved purge pressure high alarm if not resolved by the recommendations provided, high purge pressure¿which triggers the ¿purge pressure high¿ alarm message¿could be an indication of a kink in the impella rp with smart assist system catheter.In this case, the motor is no longer being purged and may eventually stop.Monitor motor current and consider replacing the impella rp with smart assist system catheter whenever a rise in motor current is seen.¿ this report is being filed as part of a retrospective review of historical records.
Event or Problem Description
The complainant reported a patient in acute myocardial infarction/cardiogenic shock was implanted with an impella rp device as additional bipella support for mechanical circulatory support.Upon insertion of the rp, the pump initially detected a purge pressure high alarm followed by a purge system blocked alarm.Appropriate trouble shooting steps were performed (i.E.Switching to a new purge cassette) however the problem persisted indicating the purge lumen of the rp was blocked.The physician insisted the pump be replaced since the patient was unstable.The replacement impella rp pump was successfully placed with the same cassette and had no issues.

• Brand Name: IMPELLA RP
• Common Device Name: TEMPORARY NON-ROLLER TYPE RIGHT 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: 20575501
• Report Number: 1220648-2024-21616
• Device Sequence Number: 8226687
• Product Code: PYX
• UDI-Device Identifier: 00813502011029
• UDI-Public: (01)00813502011029(10)2022064744(17)230228
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P170011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: IMPELLA RP
• Device Catalogue Number: 004334
• Device Lot Number: 2022064744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/01/2022
• Initial Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White