MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 IMPELLA; INTRODUCER, CATHETER (INTRODUCER)

Catalog Number	0052-3046
Medical Device Problem Codes	Fluid/Blood Leak (1250); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An impella cp was inserted via the 14fr introducer to support (b)(6) male patient who had been admitted in for a planned protected percutaneous coronary intervention (pci).The patient was in scai stage e shock at the time of pump insertion.The patient's underlying medical history was not shared.The 14fr introducer was noted to be leaking blood from the diaphragm during the pci procedure of the left main coronary artery.As the patient was in critical condition and was suffering from hypotension the team made decision to leave the pump in for hemodynamic support, but peel away the 14fr introducer.The introducer was peeled away and the repositioning sheath was inserted.The patient had blood work drawn and the hemoglobin was found to have dropped from 11g/dl to 6g/dl.This lab drop and diagnosis of hypovolemia, prompted the team to infuse 2 units of blood back to the patient.Anticoagulation necessary for the pump placement and support can contribute to access site bleeding.This patient was known to have 9,000 units of heparin anticoagulation infused and the activated clotting time was 222 seconds at time of the bleeding.The pump support was explanted after approximately 20 hours of support and successfully being weaned off the pump support.The patient survived the bleed.
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.
Additional Manufacturer Narrative
Additional information has been provided in d3.Major bleed/pdi: the cause of major bleed/pdi was not determined since product was not returned and insufficient clinical details were provided.Fluid leak: the cause of the leak was not determined since product was not returned and insufficient clinical details were provided.

• Brand Name: IMPELLA
• Common Device Name: INTRODUCER, CATHETER (INTRODUCER)
• Manufacturer (Section D): ABIOMED, INC. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 25240408
• Report Number: 1220648-2026-08052
• Device Sequence Number: 18541125
• Product Code: DYB
• UDI-Device Identifier: 00813502011692
• UDI-Public: (01)00813502011692(17)280229(10)S9652826
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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

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: S9652826
• 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: 05/12/2026
• Supplement Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 07/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White