BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIONWIRE

    MDR report key: 3060848 · Received April 16, 2013

    Report

    Report Number
    1028232-2013-01034
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    January 3, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DQX
    PMA / PMN Number
    K082935
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OUS MDR - THE PHYSICIAN WAS ATTEMPTING TO INTRODUCE AND FIND A CORRECT POSITION FOR AN LV LEAD IN THE TARGET VEIN DURING IMPLANTATION OF A CRT-P. THE GUIDE WIRE BECAME COMPLETELY UNWOUND. IT WAS POSSIBLE TO PULL THE GUIDE WIRE OUT OF THE LV LEAD, BUT THE PHYSICIAN WAS CONCERNED ABOUT PERFORATING THE VEIN. NO PERFORATION WAS NOTED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER TYPE OF GUIDE WIRE. THE GUIDE WIRE WAS CUT WITH SCISSORS TO FACILITATE REMOVING IT FROM THE LV LEAD. THERE WERE NO ADVERSE EFFECTS REPORTED FOR THE PATIENT. THIS DEVICE HAS BEEN RETURNED FOR ANALYSIS. UPON INITIAL REVIEW: "THE COMPLAINT TEXT STATES THAT THE WIRE WAS CUT WITH A SCISSORS. HOWEVER, UPON EXAMINATION OF THE GUIDE WIRE IT APPEARS THAT THE WIRE HAS FRACTURED AT THE DISTAL TIP. IT IS LIKELY THAT THIS CAUSED THE GUIDE WIRE COIL TO "UNRAVEL" AS IS DESCRIBED IN THE COMPLAINT DIALOGUE. IT IS LIKELY THAT THE USER THEN CUT THE COIL WITH A SCISSORS (AND NOT THE CORE WIRE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163519 VISIONWIRE CORONARY GUIDEWIRE DQX BIOTRONIK SE & CO. KG 352023 90015856

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization