BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GC 10F 80CM VISTA BRITE

    MDR report key: 1610886 · Received February 4, 2010

    Report

    Report Number
    9616099-2010-00092
    Event Type
    Malfunction
    Date Received
    February 4, 2010
    Date of Event
    January 26, 2010
    Report Date
    January 26, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K971572
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE CONNECTION OF Y-CONNECTOR WAS DAMAGED AND IT COULD NOT DETACH FROM THE HUB OF BRITETIP GUIDING CATHETER. THE PT WAS A (B)(6) FEMALE. THE TARGET LESION WAS UNK. THERE WAS NO CALCIFICATION AND MILD VESSEL TORTUOSITY, THE RATE OF STENOSIS WAS 0%. THE CONNECTION OF Y-CONNECTOR WAS DAMAGED AND IT COULD NOT DETACH FROM THE HUB OF BRITETIP GUIDING CATHETER. THE HUB OF THE CATHETER WAS NOT DAMAGED PRIOR TO ATTACHING Y-CONNECTOR. THERE WAS NO DIFFICULTY ATTACHING THE Y-CONNECTOR TO THE HUB. IT IS UNK IF THERE WAS ANY EXCESSIVE FORCE USED TO CONNECT THE DEVICES. IT IS UNK IF THE CONNECTION WAS FIRM. ANOTHER PRODUCT (DETAILS UNK) WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER PROBLEMS. THERE WAS NO ADVERSE EVENT AND THE PT IS IN STABLE CONDITION. THE PHYSICIAN COULD NOT CONFIRM WHETHER THE HUB OF Y-CONNECTOR WAS BROKEN OR HUB OF BRITETIP WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GC 10F 80CM VISTA BRITE CARDIOLOGY GUIDING CATHETER (DQY) DQY CORDIS DE MEXICO NA 14150564

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Y-CONNECTOR