MAUDE Adverse Event Report: ABIOMED, INC. KIT, 14FR INTRODUCER, 13CM&25CM, STERILE; INTRODUCER, CATHETER

Catalog Number	0052-3046
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	02/26/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
The impella device has not been received from the customer.Therefore, investigation of the device is not possible.Should the device or any new information be received, a supplemental mdr will be filed.
Event or Problem Description
An impella cp device was inserted into the right femoral artery in a 82-year-old female patient presenting in acute myocardial infarction (ami) and cardiogenic shock (cgs), in an out-of-hospital cardiac arrest requiring cardiopulmonary resuscitation (cpr), in scai stage e shock, on an intra-aortic balloon pump (iabp), on multiple inotropes and vasopressors, and on a ventilator for respiratory support, prior to initiation of support during the procedure, a distal perfusion catheter (dpc) was placed due to no flow around the peel-away sheath prior to removal, and no doppler distal pulses.The dpc resolved the issue.In addition, the impella kept suctioning passed p-3 then p-2.The mean arterial pressure (map) was 30-40's on the automated impella controller (aic).Bleeding and a drop in the hemoglobin occurred prior to the patient arriving to the cath lab.Blood and other blood products were transfused for volume.The physician did not attribute the bleeding and hemodynamic instability to the impella.A few hours after impella insertion the patient expired on support.The impella is conservatively being reported for death; however, is unlikely to have contributed to the patient's death, which was most likely due to the clinical condition of a critically ill patient with acute myocardial infarction, complicated by cardiogenic shock, along with the complications of stage e shock.
Additional Manufacturer Narrative
The investigation was completed.Ischemia/ppae: the root cause of the injury was unable to be determined due to insufficient clinical details.

• Brand Name: KIT, 14FR INTRODUCER, 13CM&25CM, STERILE
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): OSCOR CARIBE LLC; zona franca las americas; autopista las americas km 22; santo domingo ; DO
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24551350
• Report Number: 1220648-2026-04813
• Device Sequence Number: 9485968
• Product Code: DYB
• UDI-Device Identifier: 00813502013269
• UDI-Public: (01)00813502013269(11)250623(10)S9913594
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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: S9913594
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2025
• 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: Required Intervention; Death
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White