BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE SUPRA CORE 35 GUIDE WIRE WITH MICROGLIDE COATING

    MDR report key: 967769 · Received March 28, 2006

    Report

    Report Number
    3004742046-2006-00192
    Event Type
    Malfunction
    Date Received
    March 28, 2006
    Date of Event
    March 1, 2006
    Report Date
    March 2, 2006
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    DQX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT AND DEVICE CODES IN H10 WERE CODED BY THE MFR.

    Description of Event or Problem · 1

    DEVICE COMPLICATIONS: DIFFICULT TO USE, DETACHMENT FROM SOURCE, PHYSICAL RESISTANCE. TIME OF COMPLICATION: DURING THE PROCEDURE. SYMPTOMS: NONE. IT WAS REPORTED THAT A GUIDE WIRE WAS DIFFICULT TO USE DURING THE PROCEDURE AND HAD TO BE REMOVED IN MULTIPLE PIECES . IT WAS FURTHER NOTED THAT THE EXACT COMPLAINT WAS NOT KNOWN OR REPORTED; HOWEVER, NO PT INJURY WAS REPORTEDLY ASSOCIATED WITH THE EVENT. NO ADD'L INFO WAS AVAILABLE. SUBSEQUENTLY, A USER FACILITY WAS REC'D WHICH STATES, "HTQ SUPRA CORE WIRE HAS AN APPARENT DEFECT AT THE JUNCTURE OF THE FLOPPY END OF THE WIRE TO THE STIFF END. THE SOLDER POINT IS ROUGH WITH AN EDGE. THE WIRE WAS DIFFICULT TO USE DURING THE CATHETER EXCHANGE. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE WIRE, THE WIRE FAILED AND HAD TO BE REMOVED IN MULTIPLE SMALL PIECES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE SUPRA CORE 35 GUIDE WIRE WITH MICROGLIDE COATING GUIDE WIRE DQX GUIDANT ENDOVASCULAR SOLUTIONS NA 5122151

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN