BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTERIAL LINE KIT/1 20 G 10/CS

    MDR report key: 3800241 · Received April 30, 2014

    Report

    Report Number
    1625425-2014-00015
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    February 24, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    GDY
    PMA / PMN Number
    K780871
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON A DESCRIPTION OF THE COMPLAINT FROM THE CUSTOMER, THE DOCTOR WAS ATTEMPTING TO ADVANCE THE CATHETER AND TRIED TO WITHDRAW THE GUIDEWIRE WHEN THE WIRE STUCK IN PLACE. A SMALL INCISION WAS MADE AND THE WIRE WAS REMOVED. ANOTHER LINE WAS PLACED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. NO DISCREPANCIES WERE NOTED IN A REVIEW OF THE BATCH RECORD. GUIDE WIRES ARE 100% INSPECTED. THEY ARE THE BE FREE OF DAMAGE, FREE OF SURFACE AND COATING IMPERFECTIONS, UNCONTAMINATED, AND FREE OF ABNORMAL COLORATIONS. IF THE DOCTOR TUGGED ON THE GUIDE WIRE TO GET IT UNSTUCK, INADVERTENT STRESS PLACED ON THE GUIDE WIRE COULD CAUSE THE CORE WIRE TO BREAK LOOSE FORM THE WELDED TIP. THE IFU STATES, "DO NOT ADVANCE THE WIRE AGAINST RESISTANCE UNTIL THE CAUSE OF THE RESISTANCE HAS BEEN DETERMINED BY FLUOROSCOPY". EXCESS FORCE AGAINST RESISTANCE MAY RESULT IN DAMAGE TO THE GUIDEWIRE, OR CATHETER, OR VESSEL PERFORATION. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR ANALYSES; THEREFORE, THE EXACT ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. HOWEVER, BASED ON THE INFORMATION RECEIVED, IT IS PROBABLE THAT THE ROOT CAUSE OF THE COMPLAINT WAS DUE TO INADVERTENT STRESS ON THE GUIDEWIRE WHICH CAUSED IT TO BREAK OFF.

    Description of Event or Problem · 1

    PATIENT WAS HAVING A RIGHT FEMORAL CENTRAL LINE PLACED IN PREPARATION FOR SURGERY. WHILE ATTEMPTING TO ADVANCE THE CATHETER AND WITHDRAW THE GUIDEWIRE, THE WIRE STUCK IN PLACE. THE PHYSICIAN WAS UNABLE TO WITHDRAW THE GUIDEWIRE. VASCULAR SURGERY WAS CONSULTED. THEY MADE A SMALL INCISION AND REMOVED IT. THE PHYSICIAN STATED THAT HE GUIDEWIRE APPEARED TO HAVE UNCOILED. THE LINE WAS CUT INTO THREE PARTS TO REMOVE IT. ANOTHER LINE WAS PLACED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. SINCE THERE WERE TWO LINE PLACEMENT BOTH PACKAGE COVERS WERE SEVERED. IT IS NOT KNOWN WHICH PACKAGE HAD THE PRODUCT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258047 ARTERIAL LINE KIT/1 20 G 10/CS ARTERIAL LINE KITS GDY ARGON MEDICAL DEVICES INC. 11052803

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention