MAUDE Adverse Event Report: ABIOMED, INC. - 1220648; 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	05/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation.Investigation summary patient-device interaction/peripheral arterial ischemia: the cause of the injury was not determined due to insufficient clinical details.
Event or Problem Description
Clinical narrative: an impella cp was inserted via the 14fr introducer in the femoral artery to support the 40 year old male patient who had been admitted in with indication of acute myocardial infarction and cardiogenic shock, presenting in scai stage e shock.The underlying medical history was not shared.While on the cp support the team added va-extra corporeal membrane oxygenation (ecmo).While the cannulation of the ecmo was ongoing the team made the decision to place distal perfusion to both the ecmo and cp accessed limbs.The 14fr peel away sheath was left in during insertion and the patient had minimal peripheral pulses on all four extremities.The console did alarm for an "in aorta" alarm during the support.The pump was exhibiting the positional and placement unknown alarms.The team made decision to explant the pump at the second medical center they transported the patient to for a higher level of care at the tertiary medical center.Patient outcome is not known at this time.Limb ischemia may be influenced by patient-specific factors such as severe peripheral vascular disease, underlying critical illness, hemodynamic instability, and vascular access characteristics.
Additional Manufacturer Narrative
This is one of two related reports.This report represents the introducer and another report was submitted to represent the impella cp.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
Additional information received indicated that there was no imaging performed at the time of the alarm.The account did not reach out while preparing to transport the patient; instead, a call was received from csc.The patient was on ecmo and was not repositioned prior to the alarm.There were no concerns with the impella despite the alarms.

• 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: 25127404
• Report Number: 1220648-2026-07697
• Device Sequence Number: 10642443
• Product Code: DYB
• UDI-Device Identifier: 00813502011678
• UDI-Public: (01)00813502011678(17)280630(10)S10020644
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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: 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
• Device Lot Number: S10020644
• 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: 05/02/2026
• Supplement Date Received by Manufacturer: 05/26/2026; 05/29/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 05/28/2026; 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EXTRACORPOREAL MEMBRANE OXYGENATION.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White