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

Catalog Number	0052-3046
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	05/01/2026
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 impella cp device was inserted into the right femoral artery in a 78-year-old female patient presenting in acute myocardial infarction (ami) and cardiogenic shock (cgs), in scai stage e shock, on multiple inotropes and vasopressors, prior to initiation of support.While the patient was in the intensive care unit (icu), no distal pulses were noted.After one day on support, the family withdrew care, and the patient expired.The impella functioned at p-5 at 2.7 l/min as intended.Limb ischemia can be influenced by patient-specific factors such as peripheral vascular disease, underlying critical illness, hemodynamic instability, anticoagulation status, vasopressor support, and vascular access characteristics.The impella is being conservatively 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 and cardiogenic shock, complicated by stage e shock.
Additional Manufacturer Narrative
B5 updated with additional information.D1 revised.
Event or Problem Description
Peel away was left in.Pulses were not obtained prior to insertion of the sheath.Device was disposed of.
Additional Manufacturer Narrative
H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation and added clinical review.Corrected information has been provided in d3( manufacturer fax).Upon review, it was identified that the information was inadvertently not submitted in the initial report.The root cause of the injury was unable to be determined due to insufficient clinical details.

• Brand Name: KIT, 14FR INTRODUCER, 13CM&25CM, AMB
• 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: 25110903
• Report Number: 1220648-2026-07616
• Device Sequence Number: 10280162
• Product Code: DYB
• UDI-Device Identifier: 00813502011678
• UDI-Public: (01)00813502011678(11)250903(10)S10082877
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• 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: 05/01/2026
• Supplement Date Received by Manufacturer: 05/05/2026; 05/22/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 05/13/2026; 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2025
• 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
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White