BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTURAFLEX MULTI-LUMEN BALLOON BRACHYTHERAPY CATHETER

    MDR report key: 2441994 · Received January 30, 2012

    Report

    Report Number
    2032230-2012-00002
    Event Type
    Malfunction
    Date Received
    January 30, 2012
    Report Date
    December 12, 2011
    Manufacturer
    SENORX, INC.
    Product Code
    JAQ
    PMA / PMN Number
    K081079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER WAS UNKNOWN. THEREFORE, A MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION IS ON-GOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING MEASUREMENT OF THE LUMENS PRIOR TO TREATMENT, LUMEN # 3 WAS 6 MM LONGER THAN THE OTHER LUMENS. THE LUMEN DID NOT APPEAR TO BE COMPROMISED AND THE TREATMENT PROCEEDED WITH THE PLAN TO ROTATE THE CATHETER SO THAT LUMEN # 3 WOULD BE UTILIZED TO A LESSER EXTENT. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTURAFLEX MULTI-LUMEN BALLOON BRACHYTHERAPY CATHETER JAQ SENORX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1