BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUPER-STIFF J-TIP WIRE

    MDR report key: 24647601 · Received March 19, 2026

    Report

    Report Number
    MW5185393
    Event Type
    Death
    Date Received
    March 19, 2026
    Date of Event
    February 12, 2026
    Report Date
    March 12, 2026
    Manufacturer
    CORDIS US CORP.
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PHYSICIAN USED A SUPER-STIFF WIRE TO ADVANCE AN INTRODUCER DURING A LEADLESS PACEMAKER IMPLANT PROCEDURE. SUBSEQUENT EXAMINATIONS SUGGESTED THAT A CARDIAC PERFORATION OF THE ATRIAL APPENDAGE OCCURRED AND LED TO THE PATIENT¿S UNSTABLE CONDITION. THE PHYSICIAN SUSPECTED THAT THE PERFORATION WAS PROBABLY CAUSED BY THE STIFF WIRE. THE PATIENT DATE OF DEATH WAS ON (B)(6) 2026. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707343 SUPER-STIFF J-TIP WIRE WIRE, GUIDE, CATHETER DQX CORDIS US CORP. SUPER STIFF J-TIP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death