MAUDE Adverse Event Report: Abiomed, Inc. - 1220648 Impella; Wire, Guide, Catheter

Catalog Number	0052-3005
Medical Device Problem Codes	Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Clinical narrative: us.An impella cp with smartassist (cpsa c9) was inserted via the right femoral artery in a patient of unknown age and gender for inability to wean from cardiopulmonary bypass (cpb) following emergency coronary artery bypass grafting (cabg).The patient's comorbidities and pre-support clinical condition society for cardiovascular angiography and interventions (scai) stage were not reported.During the initial implantation attempt, vascular access was obtained via the right femoral artery under ultrasound guidance.The impella was advanced over the guidewire; however, advancement was unsuccessful and the device buckled during the procedure.The device was removed due to inability to advance the guidewire/device.No access-site complication was reported.A second impella cp was subsequently implanted via the left femoral artery under fluoroscopic guidance and was successfully advanced and positioned without further issue.
Additional Manufacturer Narrative
Related medical device reports: this guidewire device report is one of two devices associated with the event.Refer to the related manufacturer report number as noted in section h10 for the medical device report on the impella cp.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: Wire, Guide, Catheter
• 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: 50800973
• Report Number: 1220648-2026-12985
• Device Sequence Number: 10548905
• Product Code: DQX
• UDI-Device Identifier: 04260113630303
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 0052-3005
• Device Lot Number: 9464339
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2025
• 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 Sex: Unknown