MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 IMPELLA; INTRODUCER, CATHETER (INTRODUCER)

Catalog Number	0052-3046
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	04/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation and added clinical review.Corrected information has been provided in d1; d3 (manufacturer fax); e1; e3.Upon review, it was identified that the information was inadvertently not submitted in the initial report.The cause of the injury was not determined due to insufficient clinical details.
Event or Problem Description
Clinical narrative: an impella cp was inserted via the 14fr introducer at the femoral artery to support the 74 year old female patient who had been admitted in with acute myocardial infarction and cardiogenic shock, presenting in scai stage e.The underlying medical history was not shared.The physician observed minimal flow beyond the 14fr but, made choice to not remove the peel away sheath, rather place external bypass to perfuse the leg.The patient had distal pulses present when the bypass was placed.The retention of the 14fr does not follow best practices as noted in the instructions for use.The pump remains on for support to date with the leg perfusion.The patient has survived.
Additional Manufacturer Narrative
The device is not available for return.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.

• Brand Name: IMPELLA
• Common Device Name: INTRODUCER, CATHETER (INTRODUCER)
• Manufacturer (Section D): ABIOMED, INC. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 25084642
• Report Number: 1220648-2026-07517
• Device Sequence Number: 10565948
• Product Code: DYB
• UDI-Device Identifier: 00813502011678
• UDI-Public: (01)00813502011678(11)250805(10)S10055521
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0052-3046
• Device Lot Number: S10055521
• 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: 04/29/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Race: White