MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 IMPELLA; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Catalog Number	0048-0024-JP
Medical Device Problem Code	Priming Problem (4040)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by abiomed inc, or its employees that the report constitutes an admission that the product, abiomed inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
A complainant reported that a patient was implanted with an impella cp via percutaneous right femoral artery for mechanical circulatory support.In the case, the young doctor with little experience with impella insertion was in charge.They were accustomed to insertion and began priming early.After priming was finished, purge fluid was checked on the tray, but it did not flow.The young doctor was the first to correct hemodynamics, so purge fluid did not flow, but started introducing it.A senior doctor arrived at the time of introduction, and said it was essential to check if the purge fluid was flowing.Removed and checked the flow fluid of the purge again, but it did not flow.Suspected initial failure of product so a second bottle was opened.After that, it was introduced without problems.
Additional Manufacturer Narrative
Added d3 fax was omitted during initial report.Corrected d4 serial number.Updated h3 device evaluated by manufacturer to "yes".H6 investigation: type, findings, and conclusion codes and h6 component codes were updated accordingly based on the completed investigation.The cause of the priming problem could not be determined as no logs from field were returned and no issue was found with pump on returned product.

• Brand Name: IMPELLA
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT 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: 24616089
• Report Number: 1220648-2026-05417
• Device Sequence Number: 15849544
• Product Code: OZD
• UDI-Device Identifier: 00813502011371
• UDI-Public: (01)00813502011371(17)270731(10)2026743161
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P140003
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2026

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 Catalogue Number: 0048-0024-JP
• Device Lot Number: 2026743161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 04/10/2026; 06/05/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/13/2026; 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2025
• 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: 77 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian