MAUDE Adverse Event Report: Abiomed, Inc. - 1220648; Introducer, Catheter (Introducer)

Catalog Number	0052-3046
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Hypovolemia (2243)
Date of Event	09/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Impella cp smartassist was inserted via a 14 fr introducer at femoral artery access of undocumented side in a 74-year-old female patient presenting with acute myocardial infarction and cardiogenic shock.The patient's comorbidities were not documented.The patient's clinical condition prior to initiation of support was not reported according to the society for cardiovascular angiography and interventions (scai) shock classification.During insertion utilizing the abiomed-provided 14 fr introducer, vascular injury occurred.The external iliac artery was reported to have developed bleeding and an associated hematoma.The severity of the vascular injury required surgical repair by the vascular surgery team; however, the extent and details of the surgical intervention were not reported.Following identification of the vascular complication, the 14 fr introducer was peeled away and impella support was aborted.No information was provided regarding placement of an alternative mechanical circulatory support device.No pump performance data, anticoagulation information, or activated clotting time (act) values were reported, as the pump was not placed into clinical support.The patient survived the event and subsequent vascular intervention.The reported bleeding and hematoma involving the external iliac artery are consistent with a procedural vascular complication associated with arterial access.Contributing factors may include patient-specific vascular anatomy, underlying medical conditions, and anticoagulation status; however, these factors cannot be fully assessed due to limited clinical information.Because impella support was aborted prior to initiation of therapy, no device performance issues were reported.The vascular injury was managed surgically, and the patient survived the event, though a diagnosis of hypovolemic shock was made.
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.

• 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: 50886311
• Report Number: 1220648-2026-13306
• Device Sequence Number: 10664328
• Product Code: DYB
• UDI-Device Identifier: 00813502013474
• UDI-Public: (01)00813502013474(17)280630(10)S9998668
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: S9998668
• 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: 09/21/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2025
• 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 Race: White