BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 24407106 · Received February 20, 2026

    Report

    Report Number
    1220648-2026-03717
    Event Type
    Injury
    Date Received
    February 20, 2026
    Date of Event
    October 22, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. CORRECTED INFORMATION WAS PROVIDED IN B1 (IS PRODUCT PROBLEM). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN ADDED IN B5 AND B6, REGARDING SEQUENCE OF EVENTS, CLINICAL COURSE, DEVICE INTERACTION AND TEST/LAB DATA. 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

    HEMATOMA: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. FLUID LEAK: THE CAUSE OF FLUID LEAK CANNOT BE DETERMINED SINCE NO PRODUCT WAS RETURNED AND INSUFFICIENT CLINICAL DETAILS WERE PROVIDED. PD-ANY DEVICE-(CRACK): THE CAUSE OF PRODUCT DAMAGE CANNOT BE DETERMINED SINCE NO PRODUCT WAS RETURNED AND INSUFFICIENT CLINICAL DETAILS WERE PROVIDED.

    Description of Event or Problem · 0

    1M PMH HEART TRANSPLANT IN 2012. PRESENTED IN ACUTE DECOMPENSATED HF W LACTIC OF 2.8, WAS BROUGHT TO CCL FROM CICU FOR R/LHC AND BIOPSY AS PT IS S/P TRANSPLANT. RHC NUMBERS SHOWED VOLUME OVERLOAD AND SLIGHTLY REDUCED CI, IABP PLACED. LHC THEN SHOWED SEVERE LM LESION. PT BROUGHT BACK TO CCL TODAY FOR IMPELLA INSERTION RELATED TO HF SHOCK AND HRPCI. ON ARRIVAL TO CICU, THERE WAS A NEW HEMATOMA AT IMPELLA SITE, SO A FEMO STOP WAS PLACED ABOVE SITE. BLOODY URINE WAS ALSO FOUND. DURING IMPELLA CP IMPLANT PROCEDURE, THERE WERE FLUID LEAK ISSUES DUE TO A DAMAGED 25 CM INTRODUCER. THE ABIOMED REPRESENTATIVE STATED ABNORMAL AMOUNTS OF BLEEDING AROUND THE HEMOSTATIC VALVE AND SHEATH ACCESS SITE. THIS BEGAN AFTER MICROPUNCTURE FOR SINGLE ACCESS. RE-ACCESS OF THE COMPANION SHEATH AT A DIFFERENT ANGLE WAS ATTEMPTED, BUT DID NOT RESOLVE THE ISSUE. THE 25 CM INTRODUCER WAS REMOVED AND EXCHANGED WITH THE 13 CM INTRODUCER, WHICH REQUIRED THE IMPELLA CP TO BE REMOVED AND A DELAY TO TREATMENT/THERAPY. DURING THE REPLACEMENT, THERE WAS AN EVIDENT CRACK ON THE 25 CM INTRODUCER. THE IMPELLA WAS RE-IMPLANTED AND THE 13 CM INTRODUCER WAS UTILIZED AS A COMPANION SHEATH FOR SINGLE ACCESS WITHOUT BLEEDING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCES HEMATURIA ON (B)(6) 2025. IT WAS ALSO OBSERVED THAT THE PATIENT HAD ACUTE BLOODY URINE. ECHOCARDIOGRAM SHOWED SHALLOW IMPELLA, REPOSITIONED AND URINE CLEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197101 KIT, 14FR INTRODUCER, 13CM&25CM, STERILE INTRODUCER, CATHETER (INTRODUCER) DYB ABIOMED, INC. - 1220648 KIT, 14FR INTRODUCER, 13CM&25CM, STERILE S9652826

    Patients

    Seq Age Sex Outcome Treatment
    1