BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT, 14FR INTRODUCER, 13CM&25CM, STERILE

    MDR report key: 24392899 · Received February 19, 2026

    Report

    Report Number
    1220648-2026-03596
    Event Type
    Injury
    Date Received
    February 19, 2026
    Date of Event
    December 21, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN B5 (EVENT DESCRIPTION). 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 · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN B3, UPDATED EVENT DATE TO NEW VALUE: 12/21/2025. ADDITIONAL CODES WERE ADDED IN H6 (TYPE OF INVESTIGATION).

    Additional Manufacturer Narrative · 0

    PERI-PROCEDURAL ADVERSE EVENT (ISCHEMIA): THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. AS PER (B)(4) QTY 2 UNITS FOUND WITH A PARTICULATE THAT IS GREATER THAN 0.20MM, QTY 4 UNITS HAVE A TEAR ON THE OUTER POUCH, QTY 1 UNIT HAS A PUNCTURE ON THE OUTER POUCH. QTY 1 UNIT HAS DAMAGE ON THE OUTER POUCH SEAL, QTY 1 UNIT HAS STAIN ON THE OUTER POUCH. MRB TEAM MET TO REVIEW THE QTY=9 UNITS SENT TO MRB. OF THE QTY=6 UNITS SENT TO MRB FOR PACKAGING DAMAGE CONDITION, QTY=2 WERE FOUND TO BE NONCONFORMING AND DISPOSITIONED AS RTV. THE REMAINING QTY=4 UNITS SENT FOR PACKAGING DAMAGE CONDITION WERE FOUND TO BE CONFORMING TO ARTICLE SPECIFICATION REQUIREMENTS BECAUSE THERE WERE NO RIPS, TEARS, OR PUNCTURES, AND WERE DISPOSITIONED AS ACCEPT. OF THE QTY=2 UNITS SENT TO MRB FOR FOREIGN MATERIAL - PARTICULATE CONDITION, QTY=1 WERE FOUND TO BE NONCONFORMING AND DISPOSITIONED AS RTV. THE REMAINING QTY=1 UNIT SENT FOR FOREIGN MATERIAL CONDITION WERE FOUND TO BE CONFORMING TO ARTICLE SPECIFICATION REQUIREMENTS BECAUSE THE LOOSE PARTICLE WAS OUTSIDE OF THE STERILE BARRIER AND WAS DISPOSITIONED AS ACCEPT. OF THE QTY=1 UNITS SENT TO MRB FOR FOREIGN MATERIAL - ETO STAIN CONDITION, QTY=1 WERE FOUND TO BE NONCONFORMING AND WAS DISPOSITIONED AS RTV.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION INDICATES THAT PUMP INSERTION WAS SUCCESSFUL.

    Description of Event or Problem · 0

    A 27-YEAR-OLD FEMALE PATIENT TREATED WITH AN IMPELLA CP PUMP DUE TO ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK. ANGIOGRAM PERFORMED PRIOR TO SHEATH INSERTION. VESSEL MEASURED AT 5MM. PRECEDED WITH IMPELLA SHEATH INSERTION. POST INSERTION, DISTAL LIMB ISCHEMIA. PHYSICIAN PERFORMED FEM TO FEM BYPASS. LACTATE DEHYDROGENASE VALUE RISING, ADDITIONAL CONCERN FOR HEMOLYSIS DUE TO RED URINE. P LEVEL TURNED DOWN AS A RESULT AND WHEN DOWN TO P LEVEL 4, URINE WAS CLEARED. HEMOLYSIS IS CONSISTENT WITH KNOWN RISKS ASSOCIATED WITH IMPELLA CP AS LISTED IN THE INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311639 KIT, 14FR INTRODUCER, 13CM&25CM, STERILE INTRODUCER, CATHETER (INTRODUCER) DYB ABIOMED, INC. - 1220648 KIT, 14FR INTRODUCER, 13CM&25CM, STERILE S9299647

    Patients

    Seq Age Sex Outcome Treatment
    1