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

Catalog Number	0052-3046
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An impella cp was inserted percutaneously via right femoral artery access site in 51-year-old male patient for high-risk percutaneous coronary intervention (hrpci).The patient¿s comorbidities were coronary artery disease.The patient¿s clinical state prior to initiation of support was society for cardiovascular angiography intervention (scai) shock stage was not reported.During the percutaneous coronary intervention procedure, the patient experienced cardiac arrest requiring three defibrillation shocks.During defibrillation, the patient moved on the procedure table, resulting in the development of a groin hematoma at the access site.At the conclusion of the procedure, the impella cp was removed, and vascular closure was performed using one angio-seal and two perclose devices with reported good hemostasis.The patient expired approximately three hours after insertion and at the time of explant.Impella performance (p) level was not reported.The groin hematoma occurred when the patient moved during defibrillation following cardiac arrest and was associated with procedural and patient-related circumstances.There was no allegation or evidence suggesting that the impella cp or introducer malfunctioned or caused or contributed to the reported event.The death is likely attributed to the patent's declining cardiac condition and the patients continued decline, however the device cannot be conclusively ruled out as a contributing factor due to the limited clinical information.
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
• Manufacturer (Section D): Abiomed, Inc. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; +1(781)493-4967
• MDR Report Key: 50889311
• Report Number: 1220648-2026-13336
• Device Sequence Number: 9791551
• Product Code: DYB
• UDI-Device Identifier: 00813502013474
• UDI-Public: (01)00813502013474(17)290701(10)S10914052
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 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: S10914052
• 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: 09/18/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2026
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 250 LB
• Patient Race: White