BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRODUCER KIT, LOW PROFILE, 14FR

    MDR report key: 24484376 · Received March 2, 2026

    Report

    Report Number
    1220648-2026-04339
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    February 20, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D1: BRAND NAME UPDATED. D4: CATALOG UPDATED.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    CLINICIAN NARRATIVE: AN IMPELLA DEVICE WAS INSERTED VIA AN INTRODUCER SHEATH; HOWEVER, THE PATIENT¿S AGE AND SEX WERE NOT REPORTED. THE PATIENT WAS NOTED TO HAVE EXPERIENCED THROMBOSIS ASSOCIATED WITH THE INTRODUCER. NO ADDITIONAL CLINICAL DETAILS, HEMODYNAMIC PARAMETERS, COMORBID CONDITIONS, ANTICOAGULATION STATUS, PROCEDURAL VARIABLES, OR OUTCOME INFORMATION WERE PROVIDED. THROMBOSIS IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH LARGE-BORE ARTERIAL ACCESS AND INDWELLING INTRODUCER SHEATHS, PARTICULARLY IN CRITICALLY ILL PATIENTS OR IN THE SETTING OF SUBOPTIMAL ANTICOAGULATION, LOW-FLOW STATES, HYPERCOAGULABILITY, PROLONGED DWELL TIME, OR PROCEDURAL AND HANDLING FACTORS. THESE RISKS ARE DESCRIBED IN THE INSTRUCTIONS FOR USE AND ARE WELL DOCUMENTED IN THE MEDICAL LITERATURE FOR PERCUTANEOUS MECHANICAL CIRCULATORY SUPPORT SYSTEMS REQUIRING LARGE-BORE VASCULAR ACCESS. BASED ON THE LIMITED INFORMATION AVAILABLE, NO CONCLUSION CAN BE DRAWN REGARDING CONTRIBUTING PATIENT FACTORS, ANTICOAGULATION MANAGEMENT, DEVICE POSITIONING, DURATION OF SUPPORT, OR PROCEDURAL VARIABLES. THERE WAS NO INFORMATION PROVIDED TO SUGGEST A DEVICE-RELATED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539418 INTRODUCER KIT, LOW PROFILE, 14FR INTRODUCER, CATHETER (INTRODUCER) DYB ABIOMED, INC. - 1220648

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other