BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZINGER GUIDE WIRE - CRDM

    MDR report key: 4967993 · Received August 4, 2015

    Report

    Report Number
    1220452-2015-00036
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 5, 2015
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DQT
    PMA / PMN Number
    K983927
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: RECEIVED WAS A TANGLE OF COIL WIRE FROM A GUIDE WIRE. TANGLE OF COIL WIRE IS LIKELY FROM THE COMPLAINT WIRE. THE SECTION OF COIL WIRE RECEIVED HAS NO TIP ATTACHED. THIS PORTION OF WIRE IS CONSISTENT WITH THE REPORTED EVENT. ¿A SMALL THIN PART OF WIRE THAT WAS EXTRACTED OUT OF THE LEAD.¿ THIS IS ALL THAT WAS RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

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

    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).

    Description of Event or Problem · 1

    AFTER LEFT VENTRICULAR LEAD IMPLANTATION , THE GUIDEWIRE WAS FIXED IN THE LEAD. AFTER SOME ROTATION AND HEAVY PULLING, A PART OF THE GUIDEWIRE CAME OUT OF THE LEAD. AFTER THAT A SMALL THIN PART OF THE GUIDEWIRE STAYED IN THE LEAD. IT WAS EXTRACTED OUT OF THE LEAD. AFTER X RAY, A SMALL PART OF THE GUIDEWIRE STAYED DEEP IN THE VESSEL NEXT TO THE LEAD. IT WAS NOT POSSIBLE TO EXTRACT THAT SMALL PART OF THE WIRE. IT WAS NOT POSSIBLE TO GET IT OUT OF THE PATIENT. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506839 ZINGER GUIDE WIRE - CRDM OCCLUDER, CATHETER TIP DQT MEDTRONIC, INC LVZRXT180S G14A07220

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R