BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 24588893 · Received March 13, 2026

    Report

    Report Number
    1220648-2026-05198
    Event Type
    Injury
    Date Received
    March 13, 2026
    Date of Event
    November 5, 2025
    Report Date
    April 27, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    UDI-DI
    00813502011678
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION PROVIDED IN B1 AND B2. ADVERSE EVENT AND OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS WAS SELECTED IN ERROR. THE CORRECT TYPE OF REPORT (A1) IS PRODUCT PROBLEM.

    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

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN B5 (EVENT DESCRIPTION), REGARDING RESOLUTION AND INTERVENTION. ADDITIONAL CODES WERE ADDED IN H6 (HEALTH EFFECT-IMPACT CODE AND MEDICAL DEVICE PROBLEM CODE). 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

    D4 UPDATED WITH ADDITIONAL PRODUCT INFORMATION. A24 REMOVED FROM H6. A050401 ADDED TO H6. THE INVESTIGATION IS STILL ONGOING.

    Description of Event or Problem · 0

    AN 82 YEAR OLD MAN UNDERWENT HRPI WITH IMPELLA CP SUPPORT. SINGLE SITE ACCESS WAS PLANNED BUT BLEEDING WAS NOTED AROUND THE COMPANION SHEATH AND THUS THE PCI WAS PERFORMED VIA THE CONTRALATERAL FEMORAL ARTERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SECOND ACCESS SITE WAS CREATED FOR THE PCI. ONCE THE SSA COMPANION SHEATH WAS REMOVED, THERE WAS NO MORE BLEEDING. THIS SHEATH WAS ALREADY SENT BACK SEVERAL MONTHS AGO FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303807 KIT, 14FR INTRODUCER, 13CM&25CM, STERILE INTRODUCER, CATHETER (INTRODUCER) DYB ABIOMED, INC. - 1220648 S9732007 00813502011678

    Patients

    Seq Age Sex Outcome Treatment
    1