MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 KIT, 23FR INTRODUCER, 11CM, STERILE; INTRODUCER, CATHETER (INTRODUCER)

Catalog Number	2000342
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
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
An impella cp device was inserted into the right femoral artery and an impella rp flex was inserted into the right femoral vein in a 64-year-old male patient presenting in an out-of-hospital cardiac arrest requiring cardiopulmonary resuscitation (cpr), in acute myocardial infarction (ami) and cardiogenic shock (cgs), and in scai stage e shock, on multiple inotropes and vasopressors, and on a ventilator for respiratory support, prior to initiation of support.The impella was inserted for ventricular support for a high-risk percutaneous coronary intervention (pci).During the procedure, access was obtained to the right jugular vein but was lost.The sheath and guidewire came out.The physician attempted to regain access but was unsuccessful.Access was then obtained in the right femoral vein, and the rp flex was inserted.Thirty seconds later, the patient's pressures began to drop, and when verifying position, the outlet cage slipped into the right ventricle.Several attempts were made to push the rp flex back across the pulmonary artery valve, without success.The patient continued to code, and the patient expired.The device 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
Vascular dissection, patient-device interaction problem, difficult to place or position: the cause of the issue was not established as no product was returned and insufficient clinical details were provided.

• Brand Name: KIT, 23FR INTRODUCER, 11CM, 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 ; 7814934967
• MDR Report Key: 24725637
• Report Number: 1220648-2026-06081
• Device Sequence Number: 13083046
• Product Code: DYB
• UDI-Device Identifier: 00813502012910
• UDI-Public: (01)00813502012910(11)240628(10)S9131520
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 2000342
• Device Lot Number: S9131520
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2024
• 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: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic