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

Catalog Number	2000342
Medical Device Problem Codes	Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical narrative: impella rp flex was inserted percutaneously via right internal jugular vein access site in an 59-year-old female patient presenting with post-operative cardiothoracic surgery.The patient¿s comorbidities were prior coronary artery bypass graft (cabg) and known coronary artery disease (cad).The patient¿s clinical state prior to initiation of support was society for cardiovascular angiography and interventions (scai) shock stage e.The patient was medically supported by inotropes, vasopressors and respiratory support.During vascular access, difficulty was encountered while advancing the 23 fr peel-away introducer sheath.The physician removed the sheath and observed that the sheath tip was buckled inward/collapsed.A replacement introducer from a second rp kit was obtained and inserted successfully without further issue.Following rp flex insertion, a ¿placement signal not reliable¿ alarm was observed on the automated impella controller (aic) resulting in no placement signal or flows displayed.The lack of flow and placement signals being displayed had no noted impact on hemodynamic support provided or the patient.Purge pressure and purge flow remained within appropriate ranges.
Additional Manufacturer Narrative
The pump and introducer will be returned for investigation.This is one of two related reports.This report represents the introducer and another report represents the impella rp flex.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.

• 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: 50115753
• Report Number: 1220648-2026-11193
• Device Sequence Number: 18642881
• Product Code: DYB
• UDI-Device Identifier: 00813502012910
• UDI-Public: (01)00813502012910(17)280630(10)S9732175
• 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,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: 2000342
• Device Lot Number: S9732175
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2026
• Supplement Date Received by Manufacturer: Not provided; 09/14/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 08/20/2026; 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2025
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 264 LB
• Patient Race: White