BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSUREWIRE CERTUS

    MDR report key: 1401859 · Received June 10, 2009

    Report

    Report Number
    8030904-2009-00001
    Event Type
    Injury
    Date Received
    June 10, 2009
    Date of Event
    May 19, 2009
    Report Date
    June 9, 2009
    Manufacturer
    RADI MEDICAL SYSTEMS AB
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT HAD A CARDIAC INFARCT 3-4 MONTHS AGO AND RECEIVED 4 STENTS TO RECANALIZED THE CLOSED VESSEL. AT THAT TIME ADDITIONAL STENOSIS WAS DETECTED WHICH WAS EXAMINED/TREATED WHEN THE INCIDENT OCCURRED. THE PHYSICIAN HAS CONFIRMED THE WIRE GOT STUCK IN ONE OF THE STENTS. THE WIRE WAS BEEN EXAMINED UNDER THE MICROSCOPE AND THE SURFACES OF THE BROKEN PARTS HAVE BEEN EXAMINED BY SEM AND IT CAN CLEARLY BE SEEN THAT THE CORE WIRE HAS BEEN EXPOSED TO MUCH TORQUING AND TENSILE STRESS UNTIL IT BROKE. NO MATERIAL DEFICIENCIES COULD BE OBSERVED. IN THE INSTRUCTION FOR USE (IFU) IT IS WARNED THAT: "TORQUING PRESSUREWIRE AGAINST RESISTANCE MAY CAUSE DAMAGE AND/OR FRACTURE OF PRESSUREWIRE WHICH MAY LEAD TO A PORTION OF PRESSUREWIRE WHICH MAY LEAD TO A PORTION OF PRESSUREWIRE SEPARATING FROM THE TIP". "ALWAYS ADVANCED OR WITHDRAW PRESSUREWIRE SLOWLY. NEVER PUSH, WITHDRAW OR TORQUE PRESSUREWIRE IF IT MEETS RESISTANCE". IN THE SECTION ADVERSE EVENTS, IT IS STATED THAT VESSEL DISSECTION IS AMONG "POTENTIAL COMPLICATIONS WHICH MAY BE ENCOUNTERED DURING ALL CATHETERIZATION PROCEDURES". CONSIDERING THE FACT THAT THE SEM EXAMINATION INDICATES THAT THE FRACTURE OF THE WIRE WAS DUE TO EXCESSIVE FORCE AND NOT DUE TO MATERIAL DEFICIENCIES, AND THAT RELEVANT WARNINGS ALREADY ARE PRESENT IN THE IFU, NO FURTHER ACTION IS PLANNED.

    Description of Event or Problem · 1

    USER'S DESCRIPTION OF INCIDENT: "AFTER THE PRESSURE MEASUREMENT, THE PHYSICIAN WANTED TO POSITION THE WIRE (PRESSUREWIRE) DISTAL IN THE VESSEL. THE WIRE GOT STUCK IN THE VESSEL. BY REPOSITIONING THE WIRE, THE TIP TARED AND STUCK IN THE VESSEL. AFTER THREE HOUR PROCEDURE, THE REST OF THE WIRE COULD BE REMOVED. TRAGICALLY IT CAME TO A DISSECTION AND THE VESSEL WAS COMPLETELY CLOSED. THE PT GOT VENTRICULAR FIBRILLATION AND IN THE COURSE OF THE TREATMENT, THE PT HAD TO BE VENTILATED. THE PT CAME TO AN ACVB (ARTERIAL-CORONARY-VENOUS-BYPASS) - OPERATION". THE TIP OF THE WIRE COULD BE RETRIEVED. THE PT HAS RECOVERED AND IS DOING FINE ACCORDING TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSUREWIRE CERTUS GUIDEWIRE SENSOR DQX RADI MEDICAL SYSTEMS AB 091672C

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention