MAUDE Adverse Event Report: Abiomed, Inc. - 1220648 Impella; Introducer, Catheter (Introducer)

Catalog Number	0052-3046
Medical Device Problem Codes	Fluid/Blood Leak (1250); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An impella cp was inserted via the left femoral artery in a 79-year-old male patient with a history of prior coronary artery bypass graft (cabg) surgery and coronary artery disease (cad) for protected percutaneous coronary intervention (pci).Comorbidities beyond coronary artery disease were not reported.The patient's clinical state prior to initiation of support, including the society for cardiovascular angiography and interventions (scai) shock stage, was not reported.During implantation, the impella cp was inserted and the guidewire was removed.After initiation of support, the pump was noted to be entangled in the mitral valve apparatus.The device was removed, rewired, and reinserted.Following confirmation of appropriate position, the guidewire was removed and support was restarted.Bleeding was subsequently observed from the hemostatic valve around the impella catheter.Due to the severity of the bleeding, the physician elected to remove the device and replace the 14 french × 25 cm introducer sheath with a new 14 french × 25 cm introducer sheath from another kit.The impella cp was then inserted a third time and successfully positioned without further issues.Single-site access was subsequently utilized for completion of the procedure.It was noted that no blood products were administered during management of the bleeding event.Documentation noted that vascular access best practices were followed.A potential contributing factor of hemostatic valve access was noted; however, the exact cause of the bleeding could not be confirmed based on the available information.No further information regarding lab values, pump metrics, or patient hemodynamics were available at the time of reporting.The device was explanted in the procedure area.The patient survived to explant.
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.

• 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 ; +1(781)493-4967
• MDR Report Key: 50142461
• Report Number: 1220648-2026-11296
• Device Sequence Number: 10705595
• Product Code: DYB
• UDI-Device Identifier: 00813502013474
• UDI-Public: (01)00813502013474(17)280831(10)S10143670
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 0052-3046
• Device Lot Number: S10143670
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/05/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2025
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 235 LB
• Patient Race: White