MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 RP W SMART ASSIST SET, US; TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP

Catalog Number	0046-0035
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The complainant reported that an impella rp was implanted via percutaneous right femoral vein for mechanical circulatory support.The impella rp had a sensor malfunction.The procedure was successful.No patient harm was reported.
Additional Manufacturer Narrative
The impella device was not received from the customer.Therefore, the investigation of the device was not possible.Should the device or any new information be received, a supplemental report will be filed.
Additional Manufacturer Narrative
H6 investigation: type, findings, conclusion codes and h6 component codes were updated accordingly based on the completed investigation.The device was not returned; therefore, an evaluation/analysis of the device was not possible.The root cause of the placement signal issue was unable to be determined due to lack of product and data logs returned for analysis.

• Brand Name: RP W SMART ASSIST SET, US
• Common Device Name: TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): DANVERS
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24278549
• Report Number: 1220648-2026-02451
• Device Sequence Number: 21297558
• Product Code: PYX
• UDI-Device Identifier: 00813502011869
• UDI-Public: (01)00813502011869(10)2025475468(17)260131
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P170011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 01/31/2026
• Device Catalogue Number: 0046-0035
• Device Lot Number: 2025475468
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2024
• 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: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White