BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADELANTE SAFESHEATH II

    MDR report key: 24612023 · Received March 16, 2026

    Report

    Report Number
    1035166-2026-00012
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    March 4, 2026
    Report Date
    March 16, 2026
    Manufacturer
    INTEGER
    Product Code
    DYB
    UDI-DI
    10885672002388
    PMA / PMN Number
    K122084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION NOT YET AVAILABLE, EVALUATION IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETE. 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

    DR (B)(6) EXPERIENCED DIFFICULTY IN SNAPPING THE HEMOSTATIC VALVE THAT IS ATTACHED TO THE SHEATH. THE ISSUE SEEMS TO HAVE RESOLVED IN THE LAST COUPLE OF MONTHS BUT IT HAPPENS AGAIN RECENTLY. THE ADHESIVE BETWEEN VALVE IS TOO STRONG TO PREVENT A SNAPPING OF THE VALVE. THE HOSPITAL HAS NOW CHANGED BACK TO MERIT HEMOSTATIC INTRODUCERS BUT HAPPY TO USE SAFESHEATH AGAIN ONCE ISSUE RESOLVED. THE DIFFICULT IN SNAPPING THE VALVE OCCURS DURING PPM IMPLANTS WITH BELOW PATIENTS. PATIENTS ARE NOT AFFECTED BUT IT DOES TAKE PHYSICIAN LONGER TIME TO COMPLETE THE PROCEDURE. THIS ISSUE HAS BEEN REPORTED BEFORE, WE UNDERSTAND THAT THERE IS SOME CHANGES MADE TO THE MANUFACTURING PROCESS. IT WAS ALRIGHT FOR A FEW MONTHS AFTER THE MANUFACTURING PROCESS CHANGED, BUT ISSUE RE-EMERGE AGAIN IN THE RECENT MONTH. DEVICES ARE AVAILABLE TO RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673813 ADELANTE SAFESHEATH II INTRODUCER, CATHETER DYB INTEGER SS7 S10063957 10885672002388

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown