MAUDE Adverse Event Report: Abiomed, Inc. - 1220648 Impella; Temporary Non-Roller Type Left Heart Support Blood Pump

Catalog Number	0052-3005
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical narrative: an impella 5.5 device was inserted via the right axillary/subclavian artery in a 69-year-old female patient for acute decompensated chronic cardiomyopathy.The patient's comorbidities included prior coronary artery bypass grafting (cabg), coronary artery disease, and renal insufficiency.The patient's clinical condition prior to initiation of support was society for cardiovascular angiography and interventions (scai) stage d shock.During the implant procedure, while preparing the impella 5.5 for advancement, the guidewire was inadvertently passed through the side of the impella inflow cage rather than through the center of the inflow cage as intended.Resistance was encountered while crossing the aortic valve.As the physician attempted to advance the device through the graft and across the aortic valve, continued resistance was noted, and difficulty steering and advancing the device was reported.The physician was initially unaware of the guidewire position and, after multiple unsuccessful advancement attempts, became concerned that the impella motor or catheter may have been compromised.The implant procedure was subsequently aborted, and a replacement impella 5.5 device was successfully implanted.Based on the available information, the event is consistent with procedural factors related to guidewire placement through the inflow cage.The resistance encountered during aortic valve crossing and subsequent difficulty advancing the device were most likely related to the guidewire traversing the side of the inflow cage rather than the intended central lumen, which impaired steerability and advancement of the device.
Additional Manufacturer Narrative
This is one of two related reports.This report represents the guidewire and another report was submitted to represent the impella 5.5.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.

• Brand Name: Impella
• 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): Abiomed, Inc.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; +1(781)493-4967
• MDR Report Key: 50082413
• Report Number: 1220648-2026-11039
• Device Sequence Number: 13443882
• Product Code: OZD
• UDI-Device Identifier: 04260113630303
• UDI-Public: (01)04260113630303(17)280930(10)9464361
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0052-3005
• Device Lot Number: 9464361
• 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: 07/18/2026
• Supplement Date Received by Manufacturer: 07/28/2026; 09/08/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 08/05/2026; 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2025
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 189 LB
• Patient Race: White