MAUDE Adverse Event Report: Abiomed, Inc. - 1220648 Kit, 14Fr Introducer, 13cm&25cm, Sterile; Introducer, Catheter (Introducer)

Catalog Number	0052-3046
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/27/2026
Type of Reportable Event	Death
Event or Problem Description
An impella cp device was inserted via the femoral artery in a 56 year-old male patient with an indication not reported.The access side was reported as unknown.The patient¿s clinical state prior to initiation of support was society for cardiovascular angiography and interventions (scai) shock stage e.The patient's medical history was not reported.During support, a hematoma developed at the impella access site around the repositioning sheath.Hemostasis was achieved by manual pressure.It was reported that the repositioning sheath was properly placed with angle matching.No further intervention or treatments were reported.The anticoagulation status prior and during support was also not reported.It was noted that the patient did require the hemodynamic support with the use of 3 vasopressor and inotropes during support.The following morning the patient subsequently expired on support.While on support, the impella cp device operated at performance level 8 with expected flows of 3.2 liters/minute.The purge solution consisted of dextrose 5% in water with 25 milliequivalents per liter sodium bicarbonate.The reported hematoma and access site bleeding cannot be dissociated from the impella, as the bleeding occurred around the access site.The death also cannot be dissociated from the impella due to the reported bleeding.However, the death most likely attributed to the patient's underlying critical condition, as they presented in scai stage e shock and required the support with 3 vasopressors and inotropes.
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.

• Brand Name: Kit, 14Fr Introducer, 13cm&25cm, Sterile
• 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 dr.; danvers, MA 01923 ; +1(781)493-4967
• MDR Report Key: 50229587
• Report Number: 1220648-2026-11545
• Device Sequence Number: 13330486
• Product Code: DYB
• UDI-Device Identifier: 00813502013474
• UDI-Public: (01)00813502013474(17)280831(10)S10143670
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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: S10143670
• 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: 07/27/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2025
• 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; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male