BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRODUCER KIT FOR IMPELLA®

    MDR report key: 24729839 · Received March 30, 2026

    Report

    Report Number
    1035166-2026-00019
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    February 24, 2026
    Report Date
    March 30, 2026
    Manufacturer
    INTEGER HOLDINGS CORPORATION
    Product Code
    DYB
    UDI-DI
    00885672009755
    PMA / PMN Number
    K122084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS PROVIDED FOR ANALYSIS; HOWEVER, A COMPLAINT NOTIFICATION WAS PROVIDED. THE COMPLAINANT DESCRIBED A STEADY STREAM OF BLOOD FROM THE GRAFT. NO CRACKS OR VISIBLE DAMAGE WERE NOTED ON THE INTRODUCER. DESPITE THE LEAK, THE INTRODUCER REMAINED USABLE AND THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THERE WAS NO REPORTED PATIENT HARM AND NO MEDICAL INTERVENTION REQUIRED. WITHOUT THE RETURN OF THE ACTUAL DEVICE IN QUESTION FOR EVALUATION, INTEGER IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS INCIDENT. THE COMPLAINT IS NON-VERIFIABLE AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. IN CONCLUSION, BASED ON THE INFORMATION AVAILABLE AT THIS TIME IT CANNOT BE CONFIRMED THAT THE PRODUCT FAILED TO MEET REQUIREMENTS. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED AS FINDINGS DID NOT IDENTIFY A DESIGN, LABELING OR MANUFACTURING NON-CONFORMITY. IN ADDITION, THERE WAS NO NEW FAILURE MODE IDENTIFIED, AND THE RISK REMAINS ACCEPTABLE. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. INTEGER WILL CONTINUE TO MONITOR THIS EVENT TYPE AND RISK. INTEGER IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY INTEGER WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, INTEGER, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, INTEGER, OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTEGER, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    WE HAVE BEEN NOTIFIED OF A COMPLAINT INVOLVING AN INTRODUCER (MATERIAL # 0052-3006, LOT # S9649272). A U.S. COMPLAINANT REPORTED THAT DURING AN IMPELLA 5.5 WITH SMARTASSIST IMPLANTATION PROCEDURE ON (B)(6) 2026, THE 23FR PEEL-AWAY INTRODUCER WAS OBSERVED TO BE LEAKING FROM THE SIDEARM AT THE CONNECTION POINT BETWEEN THE SIDEARM AND THE INTRODUCER. THE COMPLAINANT DESCRIBED A STEADY STREAM OF BLOOD FROM THE GRAFT. NO CRACKS OR VISIBLE DAMAGE WERE NOTED ON THE INTRODUCER. DESPITE THE LEAK, THE INTRODUCER REMAINED USABLE AND THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THE PATIENT PRESENTED TO THE PHYSICIAN WITH AMI/CGS AND REMAINED ALIVE FOLLOWING THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM AND NO MEDICAL INTERVENTION REQUIRED RELATED TO THE LEAK. ADDITIONAL DEVICES USED INCLUDED AN IMPELLA 5.5 WITH SMARTASSIST S2 SET, US (1000100), LOT #2026741033, SERIAL # (B)(6). NO DAMAGE WAS NOTED TO THE IMPELLA PRODUCT. THE INTRODUCER WAS DISCARDED AFTER THE PROCEDURE AND WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794531 INTRODUCER KIT FOR IMPELLA® INTRODUCER, CATHETER DYB INTEGER HOLDINGS CORPORATION 0052-3006 S9649272 00885672009755

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown