MAUDE Adverse Event Report: Abiomed, Inc. - 1220648 Impella; INTRODUCER, CATHETER

Catalog Number	0052-3046
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	09/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An impella cp with smartassist device was inserted into the right femoral artery in an 75-year-old male patient as a bailout of a percutaneous coronary intervention (pci) of the right coronary artery (rca).Prior to impella support, the patient was classified as society for cardiovascular angiography and intervention (scai) stage d shock, indicating deterioration despite escalation of therapy.The patient was receiving multiple inotropes, vasopressors, and ventilatory support.The patient's medical history was significant for coronary artery disease (cad), dialysis, and cardiac arrest requiring cardiopulmonary resuscitation (cpr).The impella cp was implanted as bailout support and was intended to remain in place following completion of the pci procedure.After removal of the 14 french long peel-away sheath and insertion of the repositioning sheath, fluoroscopic imaging demonstrated an iliac artery perforation.In response to the event, the impella device was weaned and explanted.Vascular surgery was consulted and performed repair of the injured vessel.Subsequent review of the procedure identified that the 14 french long sheath had been inserted over a standard j-wire rather than a stiff amplatz wire.No device performance metrics were reported.The post-procedure outcome is survived at explant.Based on the available information, the reported iliac artery perforation is most likely associated with advancement of the 14 french long sheath over a standard j-wire rather than a stiff amplatz wire.In the presence of underlying vascular disease, inadequate wire support during large-bore sheath placement may increase the risk of vessel trauma, particularly within the iliac vasculature.
Additional Manufacturer Narrative
Product complaint # (b)(4).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
• 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: 50754010
• Report Number: 1220648-2026-12815
• Device Sequence Number: 9224483
• Product Code: DYB
• UDI-Device Identifier: 00813502013474
• UDI-Public: (01)00813502013474(17)290701(10)S10914054
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 09/14/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0052-3046
• Device Lot Number: S10914054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/14/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2026
• 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: 75 YR
• Patient Sex: Male