MAUDE Adverse Event Report: Abiomed, Inc. - 1220648 Kit, 14Fr Introducer, 13cm&25cm, Sterile; Introducer, Catheter (Introducer)

Catalog Number	0052-3046
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical narrative: impella cp was inserted (side not reported) in a patient (gender and age not reported) presenting with unknown indication.The patient¿s comorbidities were peripheral artery disease (pad) and peripheral vascular disease (pvd).The patient¿s clinical state prior to initiation of support was society for cardiovascular angiography and interventions (scai) shock stage was not reported.A sheath insertion was unsuccessful due to patient anatomy.A guidewire was utilized, serial pre-dilation was performed, the approximate insertion angle was reported as 45°, and no excessive force was applied during the procedure.The vessel diameter was reported as ¿4 mm for cp use.The procedure was aborted.A replacement sheath was placed, and no delivery issues were encountered.No patient harm was reported.The reported inability to insert the sheath was attributed to patient anatomy and underlying vascular conditions (pad/pvd) rather than a device-related issue.
Additional Manufacturer Narrative
Additional information was received.Only the sheath was opened and no patient information is available.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: Kit, 14Fr Introducer, 13cm&25cm, Sterile
• Common Device Name: Introducer, Catheter (Introducer)
• 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: 50174004
• Report Number: 1220648-2026-11360
• Device Sequence Number: 15514689
• Product Code: DYB
• UDI-Device Identifier: 00813502013474
• UDI-Public: (01)00813502013474(17)280401(10)S9817428
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other Health Care Professional
• 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: S9817428
• 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: 07/27/2026
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2025
• 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 Sex: Unknown