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

Catalog Number	0052-3046
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
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: impella cp was inserted via femoral artery in a 78 year old female patient for a protected pci.The patient¿s comorbidities were unknown.The patient¿s clinical state prior to initiation of support was unknown.The impella was inserted without incident.Single access was attempted with a 6fr destination sheath as the secondary sheath, it appeared that the 6fr destination was inserted to the hub of the 14fr peel away sheath, which is not the recommended practice.There was bleeding noted from the backside of the sheath hub until single access was aborted.The pci was then performed through the wrist.
Additional Manufacturer Narrative
D9 updated: the product has been returned.The investigation is still ongoing.
Additional Manufacturer Narrative
Corrected information was provided in d3, e1 and g4.Upon review, it was identified that these were inadvertently omitted from the initial report.Updated h3 to ¿yes¿ as the device was received and evaluated.H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation.The cause of the fluid leak is most likely an insufficient seal of the hemostatic valve but proximal cause of it cannot be established.Scar (b)(4) was opened to investigate valve leak complaints at the supplier.There is potential that the device interaction may have exacerbated/revealed the pre-existing insufficient seal, but since there was no physical damage seen, the cause cannot further be established.

• Brand Name: IMPELLA
• 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: 24697999
• Report Number: 1220648-2026-05950
• Device Sequence Number: 13377804
• Product Code: DYB
• UDI-Device Identifier: 00813502013269
• UDI-Public: (01)00813502013269(11)250312(10)S9648568
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 04/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0052-3046
• Device Lot Number: S9648568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/30/2026; 05/18/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 04/20/2026; 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2025
• 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
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White