BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND EX .014"/205 PLATINUM

    MDR report key: 805573 · Received January 4, 2007

    Report

    Report Number
    6000078-2007-00002
    Event Type
    Malfunction
    Date Received
    January 4, 2007
    Date of Event
    November 30, 2006
    Report Date
    December 11, 2006
    Manufacturer
    NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP
    Product Code
    DQX
    PMA / PMN Number
    K923480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS RETURNED TO THE MFR ON 12/27/06 FOR EVAL. AN INVESTIGATION ON THE DEVICE IN QUESTION HAS BEEN INITIATED. BASED ON THE INFO KNOWN AT THIS TIME, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. IF FURTHER SIGNIFICANT INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL FOLLOW.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC (BSC) ON 12/11/06 THAT A CUSTOMER ENCOUNTERED PROBLEMS WITH A GUIDEWIRE DURING PREPARATION. ACCORDING TO THE CUSTOMER: "WIRE [DEVICE IN QUESTION] SPLIT INTO TWO WHILE DR WAS HOLDING IT. IT WAS NOT IN THE PT AND WAS REPLACED WITH A NEW UNIT. PROCEDURE COMPLETED WITHOUT INCIDENT." NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND EX .014"/205 PLATINUM 74 HAP: GUIDEWIRE DQX NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP 46-808 8861589

    Patients

    Seq Age Sex Outcome Treatment
    1 *