MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 KIT, 14FR INTRODUCER, 13CM&25CM, STERILE; INTRODUCER, CATHETER (INTRODUCER)

Catalog Number	0052-3046
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Hemodynamic instability (4868)
Date of Event	02/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical review/rationale: an impella cp was attempted via right femoral artery in a 71 year old male admitted for a cardiac ablation.The patient¿s comorbidities were unknown.The patient¿s clinical state prior to initiation of support was identified as scai shock stage a.During implant, the device could not be implanted due to patient anatomy.Due to tortuosity of the vessels, the introducer sheath kinked and attempts to pass through vasculature were unsuccessful.The cp implant was aborted and the ablation proceeded without impella support.The delivery issue and damaged/kinked introducer sheath will be conservatively reported for hemodynamic instability due to temporary hemodynamic support interruption during the position attempts, however the attempts and removal were performed with no consequence to the patient.
Additional Manufacturer Narrative
This is one of two related reports.This report represents the introducer and another report represents 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.
Additional Manufacturer Narrative
Upon review, it was identified that the.Manufacturer fax (d3) was inadvertently omitted in error; the complete fax number has now been provided.Upon review, it was identified that the.Manufacturer contact fax number (g1) was inadvertently omitted in error; the complete fax number has now been provided.H6 investigation: type, findings, and conclusion codes were updated accordingly based on the completed investigation.

• 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): OSCOR CARIBE LLC; zona franca las americas; autopista las americas km 22; santo domingo ; DO
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24470375
• Report Number: 1220648-2026-04104
• Device Sequence Number: 10262211
• Product Code: DYB
• UDI-Device Identifier: 00813502013269
• UDI-Public: (01)00813502013269(11)250228(10)S9596070
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,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: S9596070
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2025
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 80 KG