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

Catalog Number	0052-3009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/07/2026
Type of Reportable Event	Death
Event or Problem Description
An impella 5.5 device was inserted via the right axillary artery in a 72-year-old male patient presenting with cardiomyopathy, with a history of known coronary artery disease and diabetes mellitus.The patient¿s comorbidities were unknown.The patient¿s clinical state prior to initiation of support was identified as scai shock stage d.The patient was previously in the cath lab and received anti-platelet and blood thinners for pci.Three hours after receiving anticoagulation, the patient was taken to the or for impella 5.5 placement.The patient was noted to be very oozy, requiring a blood transfusion and ddavp.Surgical site bleeding occurred at the axillary site, as well as bleeding from the urinary catheter and all access sites (iv, arterial line, endotracheal tube).A drain was placed per hospital protocol and collected 200 cc of blood in about 30 minutes.The surgical team attributed all bleeding to the anti-platelet load and anticoagulation medications given in the cath lab.One unit of packed red blood cells was administered.Other contributing factors included cath lab pci with anti-platelet medications and blood thinners.The patient expired on support.The major bleed is consistent with access-site complications and the anticoagulation and purge requirements associated with impella support, compounded by cath lab pci with anti-platelet medications and blood thinners.The device is being conservatively reported for death; however, the death is most likely attributed to the patient¿s underlying critical condition as they presented in scai shock stage d.
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
Corrected information was provided in e1 (zip code extension).Upon review, it was identified that it was inadvertently omitted from the initial report.Corrected information was provided in e3 (initial reporter occupation).Upon review, it was identified that it was inadvertently submitted in error in the initial report.H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation.The cause of the bleeding at the access site was use related due anticoagulants given.

• Brand Name: INTRODUCER
• 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 ; 7817390590
• MDR Report Key: 24863319
• Report Number: 1220648-2026-06714
• Device Sequence Number: 21150103
• Product Code: DYB
• UDI-Device Identifier: 00885672009755
• UDI-Public: (01)00885672009755(17)280531(10)2039789
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 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: 0052-3009
• Device Lot Number: LN 2039789 / UPC 0088567200975
• 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: 04/07/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2025
• 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: Death
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American