BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTURA MULTI LUMEN BALLOON CATHETER

    MDR report key: 2132561 · Received June 10, 2011

    Report

    Report Number
    2032230-2011-00007
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    June 29, 2010
    Report Date
    July 26, 2010
    Manufacturer
    SENORX, INC.
    Product Code
    JAQ
    PMA / PMN Number
    K081079
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS RECEIVED. AS THE LOT NUMBER WAS RECEIVED, A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) COULD BE PERFORMED. THE DHR WAS REVIEWED AND THERE WAS NO INFO TO SUGGEST THAT THE REPORTED ISSUE WAS RELATED TO THE MFG OF THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A PROCEDURE TO IMPLANT A BALLOON FOR BREAST BRACHYTHERAPY, THE PT LEFT THE FACILITY DOING WELL; HOWEVER, WHILE SHE WAS WALKING TO ONCOLOGY FOR RADIATION TREATMENT, THE PT FELT THE BALLOON POP AND THE BREAST BEGAN BLEEDING. WHEN SHE ARRIVED AT ONCOLOGY, THE PHYSICIAN COULD NOT STOP THE BLEEDING, SO THE PT WAS TRANSPORTED ON A STRETCHER BACK TO THE SURGEON'S OFFICE. WHEN THE PT ARRIVED AT THE SURGEON'S OFFICE, THE PT'S BLOOD PRESSURE WAS UNSTABLE. THE PT WAS DIAPHORETIC, DISORIENTED, AND LOST CONSCIOUSNESS FOR A SHORT TIME. THE SURGEON'S OFFICE HAD THE PT TRANSPORTED TO THE ER. THE PT WAS ADMITTED AND REQUIRED A BLOOD TRANSFUSION; HOWEVER, SPECIFIC TREATMENT INFO IS NOT KNOWN. THE PT IS REPORTEDLY DOING BETTER; HOWEVER, THE PT LEFT THE PRACTICE AFTER THIS INCIDENT AND UNDERWENT RADIATION TREATMENT AT ANOTHER FACILITY. IT SHOULD BE NOTED THAT THE BALLOON IMPLANT PROCEDURE WAS SUCCESSFUL AND THE PT DID NOT BLEED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTURA MULTI LUMEN BALLOON CATHETER JAQ SENORX, INC. M10042002

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R