BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESHEATH® II

    MDR report key: 24625964 · Received March 18, 2026

    Report

    Report Number
    1035166-2026-00013
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    February 17, 2026
    Report Date
    March 18, 2026
    Manufacturer
    INTEGER
    Product Code
    DYB
    UDI-DI
    30891492002365
    PMA / PMN Number
    K122084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    IT WAS REPORTED THAT, PHYSICIAN WAS IN THE PROCESS OF GAINING FEMORAL ACCESS, VALVE ON THE FIRST SSL10 WAS NOT WORKING. WITH ASPIRATION, PHYSICIAN NOTED ONLY AIR COMING BACK AND SUSPECTED A LEAK IN THE VALVE. SECOND SSL10 WAS OPENED FROM THE SAME BOX, SAME LOT NUMBER AND AGAIN THE SAME ISSUE OCCURRED. A THIRD SSL10 FROM A NEW BOX WAS OPENED (ALSO SAME LOT NUMBER) WHICH WORKED FINE. PHYSICIAN WAS THEN ABLE TO CARRY ON GAINING ACCESS AND PROCEDURE CONTINUED ON WITH NO ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. BOTH THE TWO SHEATHS WITH VALVE ISSUES WERE COLLECTED AND WILL BE SENT BACK. (B)(6) 2026 CUSTOMER REPORTED THE TYPE OF PROCEDURE AS PULMONARY VEIN ISOLATION (PVI) WITH PULSESELECT PULES FIELD ABLATION (PFA) SYSTEM. NORMAL PATIENT ANATOMY. NO DELAY WITH PROCEDURE. ITEM HAS ARRIVED AT MEDTRONIC WAREHOUSE YESTERDAY. THIS ITEM IS BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693304 SAFESHEATH® II INTRODUCER, CATHETER DYB INTEGER SSL10 S10051640 30891492002365

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown