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

Catalog Number	0052-3006
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/26/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Upon review by the investigation team, it was determined that a report was needed against the introducer.This is one of two related reports.This report will represent the introducer and another report was already submitted to represent the axillary insertion clamp.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 5.5 was inserted via the right axillary artery via the abiomed provided introducer kit, to support the 73 year old male with acute decompensated chronic cardiomyopathy, presenting in scai stage e shock.The underlying medical history was not shared.The surgeon placed the pump and felt that the graft lock clips were not tight enough and less tight than usual, which lead to blood loss/leaking around the sheath and graft.The team replaced the sheath with a new sheath and support proceeded.There was no noted harm from the product replacement.The team did note that all best practices for access were followed.The support was ongoing for over 5 days and then the team made decision to withdraw care.While on the support the 5.5 device functioned as intended at p-8 at 4.7l/min with d5w sodium bicarbonate in the purge solution.There was no allegation that the sheath leak contributed to the patient outcome.The death is being conservatively reported; however, based on the available information, the patient¿s death is not attributed to the event describe and is more likely attributable to the reported cardiomyopathy, presenting in scai stage e.

• 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: 25349032
• Report Number: 1220648-2026-08314
• Device Sequence Number: 21407979
• Product Code: DYB
• UDI-Device Identifier: 00885672009755
• UDI-Public: (01)00885672009755(17)280430(11)250514(10)S9649282
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 0052-3006
• Device Lot Number: S9649282
• 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: 05/25/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2025
• 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: Required Intervention; Death
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White