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

Catalog Number	0052-3009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	03/15/2026
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
Clinical rationale: an impella 5.5 device was inserted via the right axillary artery in a 63-year-old male patient presenting with cardiomyopathy, scai shock stage e.The patient¿s comorbidities were unknown.The care team noted a small hematoma around the right axillary impella insertion site with a small amount of oozing.Manual pressure was applied, bleeding stopped, and the hematoma stabilized and began to shrink.The patient remains on support.The reported hematoma is consistent with access-site complications and the anticoagulation/purge requirements associated with impella support.
Additional Manufacturer Narrative
D6b: explantation day, month and year added.
Additional Manufacturer Narrative
Updated information: h6 component code changed to g07003.The investigation for the hematoma has been completed.No product was returned.The cause of the bleed was not determined due to insufficient clinical details.

• Brand Name: AXILLARY INSERTION KIT
• 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: 24681457
• Report Number: 1220648-2026-05880
• Device Sequence Number: 9652805
• Product Code: DYB
• UDI-Device Identifier: 00813502013269
• UDI-Public: (01)00813502013269(11)250107(10)1909725
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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
• Report Date (Section B): 05/12/2026

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: 0052-3009
• Device Lot Number: 1909725
• 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: 03/16/2026
• Supplement Date Received by Manufacturer: 04/06/2026; 05/11/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/08/2026; 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2025
• 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: Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White