BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZINGER GUIDE WIRE - CRDM

    MDR report key: 3990705 · Received August 8, 2014

    Report

    Report Number
    1220452-2014-00052
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MEDTORNIC, INC
    Product Code
    DQX
    PMA / PMN Number
    K983927
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE GUIDEWIRE WAS RETURNED, ANALYZED AND THE GUIDEWIRE WAS BROKEN. THE GUIDEWIRE WAS DAMAGED AND WAS UNRAVELED. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST IMPLANT OF THE LEFT VENTRICULAR (LV) LEAD, THE LEAD PULLED BACK CAUSING HIGH THRESHOLDS. THE DOCTOR ADVANCED THE LV LEAD AND WENT TO PULL BACK GUIDEWIRE WHEN IT TANGLED UP ON ITSELF. THE DOCTOR WAS UNABLE TO PULL GUIDEWIRE BACK. IT WAS ALSO NOTED THE GUIDEWIRE BROKE IN THE VESSEL CAUSING SPASM OR OCCLUDED BUT THE DOCTOR WAS NO LONGER ABLE TO CANNULATE THAT VESSEL WHICH WAS THE OPTIMAL VESSEL. THE GUIDEWIRE WAS LEFT IN THE VESSEL. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468194 ZINGER GUIDE WIRE - CRDM WIRE, GUIDE, CATHETER DQX MEDTORNIC, INC LVZRMS180J

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Hospitalization| R