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	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation into the placement signal issue has been completed.The impella rp was returned for investigation.Data logs showed that the "epm sensor defect" alarm (#701) triggered immediately upon initially plugging in the pump.The placement signal immediately spiked to 3000 upon connecting the pump, followed by the occurrence of the "placement signal not reliable" alarm.Disconnecting and reconnecting the impella did not resolve the issues.The raw placement signal reading averaged just below 1000 during this time.No external damage or abnormalities were found on the returned pump.Upon connecting the pump to an aic, the placement signal spiked out of range and the "placement signal not reliable" alarm reproduced.Electrical resistance testing revealed open lines between motor phases 1 and 2 and 2 and 3, as well as between s+/s- phases.There was no evidence of any use-related issue causing damage to the wiring.Therefore, it was concluded that the cause of the placement signal issue was an open electrical line.This report is being filed as part of a retrospective review of historical records.
Event or Problem Description
The complainant reported a placement signal not reliable alarm during use of the device.A decision was made to explant and replace the impella.No reported harm or injury to the patient.

• 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: 20570280
• Report Number: 1220648-2024-21543
• Device Sequence Number: 20703291
• Product Code: PYX
• UDI-Device Identifier: 00813502011029
• UDI-Public: (01)00813502011029(10)2023204406(17)240228
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 02/28/2024
• Device Model Number: IMPELLA RP
• Device Catalogue Number: 004334
• Device Lot Number: 2023204406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2022
• 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: 53 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White