MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 PUMP 382 PUMP SET (US); TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Catalog Number	1000413
Medical Device Problem Codes	Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	02/26/2026
Type of Reportable Event	Death
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
Impella cp 10 was inserted through the 14fr low profile sheath via the femoral artery in a 70 year old male who presented in ami/cgs without incident.The patient¿s comorbidities were unknown.The patient¿s clinical state prior to initiation of support was identified as scai shock stage d.Post procedure, in preparation to the icu, the physician had difficulty with blue locking mechanism due to it being turned to the locked position prior to attempting to lock to sheath.Once this was realized, correct locking position to the sheath was obtained and the site was dressed in standard fashion.While on support the device functioned as expected for the set p level, p-9 / 3.5l/min.However, the patient experienced ventricular tachycardia storm and expired while on support.The arrythmia and patient outcome is most likely due to the patients clinical presentation of stage d cardiogenic shock.
Additional Manufacturer Narrative
H1: corrected from serious injury to death.
Additional Manufacturer Narrative
Corrected data: removed a24 from h6.The investigation is still ongoing.
Additional Manufacturer Narrative
H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation and added clinical review.The cause of the ventricular tachycardia was not determined due to insufficient clinical details.The cause of the difficulty securing the integrated sheath lock to the sheath was likely use-related as it was turned to the locked position prior to attempting to lock to sheath.

• Brand Name: PUMP 382 PUMP SET (US)
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): DANVERS
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7817390590
• MDR Report Key: 24539892
• Report Number: 1220648-2026-04661
• Device Sequence Number: 9027190
• Product Code: OZD
• UDI-Device Identifier: 00813502013566
• UDI-Public: (01)00813502013566(10)2026810728(17)271130
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/31/2026

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: 1000413
• Device Lot Number: 2026810728
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 03/17/2026; 03/27/2026; 04/27/2026
• Initial Report FDA Received Date: 03/07/2026
• Supplement Report FDA Received Date: 03/18/2026; 03/31/2026; 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2025
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Hispanic
• Patient Race: White