BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZINGER GUIDE WIRE - CRDM

    MDR report key: 7090986 · Received December 7, 2017

    Report

    Report Number
    1220452-2017-00126
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    October 25, 2017
    Report Date
    March 1, 2019
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DQT
    PMA / PMN Number
    K983927
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: SOME OF THE GUIDEWIRE WAS RETURNED AND ANALYZED. THE ANALYSIS INDICATED THAT THE GUIDEWIRE WAS UNRAVELED. VISUAL ANALYSIS OF THE LEAD INDICATED DAMAGE DURING USE. 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, AFTER PLACING THE LEAD IN THE TARGET VEIN, THE PHYSICIAN WAS USING THE SUPPORT GUIDEWIRE WITH THE LEAD AND WHEN PULLING THE GUIDEWIRE BACK, IT GOT STUCK IN THE VESSEL, WHICH WAS VERY THIN. WITH THE RETRACTION MOVEMENT, THE GUIDEWIRE STRETCHED AND BROKE INTO TWO PIECES; ONE PART REMAINED INSIDE THE LEAD AND ALSO OUT OF THE DISTAL PART OF THE LEAD, IN THE VEIN. THE OTHER PIECE WAS STILL IN THE PHYSICIAN'S HAND. THE PHYSICIAN DECIDED TO LEAVE THE LEAD WITH THE GUIDEWIRE IN PLACE AND REMOVED THE REST OF THE DELIVERY SYSTEM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869525 ZINGER GUIDE WIRE - CRDM OCCLUDER, CATHETER TIP DQT MEDTRONIC, INC LVZRXT180J G15A02720

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR