BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRODUCER, CATHETER (INTRODUCER)

    MDR report key: 24818309 · Received April 8, 2026

    Report

    Report Number
    1220648-2026-06526
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    March 31, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    UDI-DI
    00813502013474
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REVIEW, IT WAS IDENTIFIED THAT THE MANUFACTURER FAX (D3) WAS INADVERTENTLY OMITTED IN ERROR; THE COMPLETE FAX NUMBER HAS NOW BEEN PROVIDED. UPDATED H3 DEVICE EVALUATED BY MANUFACTURER. H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF THE INTRODUCER VALVE LEAK WAS AN INSUFFICIENT VALVE SEAL, SINCE A LEAK WAS REPRODUCED WITH INSERTED DILATOR WITHIN THE LEAK SPECIFICATION LIMIT.

    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

    CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE 14FR X25CM INTRODUCER AT THE FEMORAL ARTERY TO SUPPORT THE 72-YEAR-OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH KNOWN CORONARY ARTERY DISEASE AND PLAN FOR A PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). THE UNDERLYING MEDICAL HISTORY WAS NOT SHARED. AFTER INSERTION WITH THE 14FR THE TEAM OBSERVED A LEAK OF BLOOD FROM A CRACK IN THE 14FR INTRODUCER. THE TEAM MADE DECISION TO REMOVE AND REPLACE WITH THE SHORTER 14FR X13CM INTRODUCER. ONCE DONE, THE ISSUE RESOLVED AND SUPPORT WAS SUCCESSFUL WITH THE CP FOR THE PCI. AFTER THE PCI WAS COMPLETED, THE PUMP WAS EXPLANTED AND PATIENT SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90573 INTRODUCER, CATHETER (INTRODUCER) DYB ABIOMED, INC. - 1220648 S10055521 00813502013474

    Patients

    Seq Age Sex Outcome Treatment
    1