BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZINGER GUIDE WIRE - CRDM

    MDR report key: 3152530 · Received June 7, 2013

    Report

    Report Number
    1220452-2013-00031
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    MEDTORNIC, INC
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - THE GUIDEWIRE WAS RETURNED AND ANALYZED. THE STYLET/GUIDEWIRE WAS BROKEN, DAMAGED AND KINKED/BUCKLED,

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, WHEN THE PHYSICIAN TRIED TO PULL THE GUIDEWIRE BACK, IT BROKE. A 2 CENTIMETER LONGPIECE OF THE GUIDEWIRE REMAINED IN THE CORONARY SINUS OUTSIDE THE LEAD. THE PATIENT WILL BE MONITORED AND FOLLOWED UP TO CHECK THE PERFORMANCE OF THE LEAD. THE LEAD REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253142 ZINGER GUIDE WIRE - CRDM WIRE, GUIDE, CATHETER DQX MEDTORNIC, INC LVZRXT180S GP653

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening