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

Model Number	RP W SMART ASSIST SET, US
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted as part of a retrospective review of optical signal issues in accordance with fda recommendation.The pump was returned for analysis and the 5s parameters showed a hard optical sensor failure.A light continuity test was performed and the light leaked out the sensor face indicating that the optical fiber was intact.The optical sensor was imaged while still on the pump and an irregularity was noted in the sensor face.The cannula was removed to get better visualization of the sensor face.A puncture could be seen in the silicone, the source of the small punctures likely external to the sensor and punctured inward toward the cavity.The data logs confirm a hard optical failure on the 6th day of support.The root cause of the optical issue was determined to be a damaged sensor face due to external material puncturing the sensor face.A review of the device history record (dhr) for the suspect device, applicable quality notifications, and historical complaint data was conducted.This review revealed that the product met all manufacturing release criteria, and no product deficiencies were identified at the time product was manufactured and released to the customer.All pertinent information available to abiomed has been submitted at this time.
Event or Problem Description
The complainant reported that an impella rp pump was implanted in a patient for circulatory support.During support, there was loss of placement signal.The team decided to not replace the pump and the patient remained on support.There was 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 ; 22 cherry hill dr.; danvers, MA 01923
• MDR Report Key: 23059304
• Report Number: 1220648-2025-31469
• Device Sequence Number: 12953212
• Product Code: PYX
• UDI-Device Identifier: 00813502011869
• UDI-Public: (01)00813502011869(10)2023229871(17)240731
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P170011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 09/15/2025

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: 07/31/2024
• Device Model Number: RP W SMART ASSIST SET, US
• Device Catalogue Number: 0046-0035
• Device Lot Number: 2023229871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• 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: 57 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White