MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 KIT, 14FR INTRODUCER, 13&25 CM, ABMD; INTRODUCER, CATHETER (INTRODUCER)

Catalog Number	0052-3046
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	04/07/2026
Type of Reportable Event	Death
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
Clinical narrative: an 86-year-old male with acute myocardial infarction complicated by cardiogenic shock, with a pre-support clinical state consistent with scai shock stage e, presented to the emergency department on (b)(6) 2026 following cardiac arrest with return of spontaneous circulation.The care team elected to proceed to the cardiac catheterization laboratory for a left heart catheterization with planned impella cp support.Percutaneous access was obtained in the right femoral artery, and a 14 fr x 13 cm peel away sheath was inserted.During access, the patient experienced recurrent cardiac arrest.Multiple rounds of advanced cardiac life support were performed without sustained recovery, and the patient¿s family elected to withdraw care.As a result, the impella cp device was not opened or implanted due to the ongoing arrest and resuscitation efforts.The patient expired.There were no allegations of device malfunction or performance issues.The death is conservatively being reported to the impella cp but is unlikely related because it was not inserted, having an active arrest is most likely attributed to patients underlying critical condition as they presented in scai stage e shock on multiple inotropes and pressors and was ventilated for respiratory support.
Additional Manufacturer Narrative
D1 brand name was inadvertently omitted on the initial manufacturer device report.
Additional Manufacturer Narrative
Corrected information was provided in d3 (manufacturer fax).Upon review, it was identified that it was inadvertently omitted from the initial report.H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation.The root cause of the injury was unable to be determined due to insufficient clinical details.

• Brand Name: KIT, 14FR INTRODUCER, 13&25 CM, ABMD
• 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: 24979970
• Report Number: 1220648-2026-07099
• Device Sequence Number: 9642770
• Product Code: DYB
• UDI-Device Identifier: 00813502011678
• UDI-Public: (01)00813502011678(17)280430(10)S9732021
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: S9732021
• 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: 04/20/2026
• Supplement Date Received by Manufacturer: 04/30/2026; 05/19/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 05/06/2026; 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2025
• 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: Death
• Patient Age: 86 YR
• Patient Sex: Male