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

Catalog Number	0052-3006
Medical Device Problem Codes	Break (1069); Difficult to Flush (1251)
Health Effect - Clinical Code	Hemodynamic instability (4868)
Date of Event	03/18/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
H6 codes were updated.
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
An impella 5.5 device was inserted via the right axillary artery in a 67-year-old male patient presenting with cardiomyopathy, scai shock stage e.The patient¿s comorbidities were unknown.The axillary sheath stop-cock did not function appropriately and did not flush correctly.The patient subsequently expired on support.The device will be conservatively reported for death; however, the death is most likely attributable to the severity of the underlying cardiomyopathy and cardiogenic shock associated with scai shock stage e.
Additional Manufacturer Narrative
H6: investigation: type, findings, conclusion codes and h6 component codes were updated accordingly based on the completed investigation.The device was not returned; therefore, an evaluation/analysis of the device was not possible.The cause of the injury was unable to be determined due to insufficient clinical details.The cause of difficulty flushing introducer cannot be determined since no product was returned and insufficient clinical details were provided.

• Brand Name: IMPELLA
• Common Device Name: INTRODUCER, CATHETER (INTRODUCER)
• Manufacturer (Section D): ABIOMED, INC. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24697831
• Report Number: 1220648-2026-05947
• Device Sequence Number: 10166988
• Product Code: DYB
• UDI-Device Identifier: 00885672009755
• UDI-Public: (01)00885672009755(17)280401(10)S9834148
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Physician
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0052-3006
• Device Lot Number: S9834148
• 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: 03/18/2026
• Supplement Date Received by Manufacturer: 04/13/2026; 05/07/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 04/17/2026; 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White