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

Catalog Number	0052-3006
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	05/08/2026
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 narrative: an impella 5.5 was inserted via the direct surgical access at the aorta for the patient admitted in with plan for a coronary artery bypass graft (cabg) surgery due to multivessel coronary artery disease.The patient presented at scai stage e shock at the elective pump implant.The other underlying medical history was not shared.The 5.5 was placed via the 23fr sheath and 10mm gelweave graft.The instructions for use speak to a 10mm x20 hemashield platinum graft.After the graft was accessed with the 23fr introducer the team applied the graft locks, however there was persistent bleeding outside the distal end of the graft.To remedy the bleed they had to place 3 heavy silk ties to achieve hemostasis.The troubleshooting was necessary despite the team using all best practices at the access.Bleeding in this clinical context is a known and expected risk associated with impella 5.5 support, particularly in the setting of major cardiac surgery and direct surgical aortic access.The pump remained on for support to date till wean and explant.No other intervention, such as blood product delivery, had been deemed necessary.The patient survives.
Additional Manufacturer Narrative
H6 medical device problem code a01 was inadvertently omitted on the initial manufacturer device report.
Additional Manufacturer Narrative
Additional information has been provided in d3.Corrected information has been provided in h3.Investigation summary: fluid leak / patient-device interaction / major bleed: the cause of the bleeding was not determined due to the introducer returned peeled away, preventing reproduction testing, and insufficient clinical details.

• 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: 25199812
• Report Number: 1220648-2026-07934
• Device Sequence Number: 18644398
• Product Code: DYB
• UDI-Device Identifier: 00885672009755
• UDI-Public: (01)00885672009755(11)250805(10)S9913578
• 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: 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0052-3006
• Device Lot Number: S9913578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Supplement Date Received by Manufacturer: 05/08/2026; 06/29/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 06/02/2026; 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White