BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRODUCER, CATHETER (INTRODUCER)

    MDR report key: 24766808 · Received April 2, 2026

    Report

    Report Number
    1220648-2026-06313
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    March 26, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    UDI-DI
    00813502011678
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: CORRECTED CATALOG NUMBER FROM INTRODUCER TO 7FR SINGLE ACCESS SHEATH PER A REVIEW OF THE COMPLAINT FILE.

    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.

    Additional Manufacturer Narrative · 0

    SECTION D4 PRIMARY UDI NUMBER HAS BEEN UPDATED.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP WAS PLACED VIA A SINGLE ACCESS AT THE FEMORAL TO SUPPORT A 72 YEAR OLD FEMALE PATIENT WHO HAD BEEN ADMITTED IN WITH KNOWN CORONARY ARTERY DISEASE, WITH A PLAN FOR THE PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). OTHER MEDICAL HISTORY WAS NOT SHARED. THE 14FR INTRODUCER AND 7FR COMPANION SHEATH WERE PLACED AND THERE WAS AN OOZE NOTED. THE TEAM REMOVED THE 7FR COMPANION SHEATH AND ACCESSED THE CONTRALATERAL LEG FOR THE PUMP AND PCI ACCESSES. THIS INTERVENTION RESOLVED THE BLEED. NO BLOOD PRODUCTS WERE DEEMED NECESSARY. AT THE CONCLUSION OF THE PCI ALL PRODUCT WAS WEANED AND REMOVED. PATIENT SURVIVED. ANTICOAGULATION NECESSARY FOR THE PUMP PLACEMENT AND SUPPORT CAN CONTRIBUTE TO ACCESS SITE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15207 INTRODUCER, CATHETER (INTRODUCER) DYB ABIOMED, INC. - 1220648 S9913598 00813502011678

    Patients

    Seq Age Sex Outcome Treatment
    1