BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE

    MDR report key: 938049 · Received April 13, 2007

    Report

    Report Number
    6000125-2007-00019
    Event Type
    Malfunction
    Date Received
    April 13, 2007
    Date of Event
    March 19, 2007
    Report Date
    March 19, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORK
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS BEEN RECEIVED BY THIS MANUFACTURER, BUT A PHYSICAL EVALUATION HAS NOT YET BEEN PERFORMED. AT THIS TIME, WE ARE UNABLE TO DETERMINE IF THE DEVICE MET SPECIFICATIONS OR THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THIS EVENT. A FIFTEEN (15) MONTH COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THIS PRODUCT. NO ADVERSE TREND HAS BEEN IDENTIFIED FOR THIS PRODUCT/DEVICE FAMILY.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT IN 2007, A THERAPEUTIC EMBOLIZATION PROCEDURE WAS PERFORMED ON A FEMALE PT. DURING THIS PROCEDURE, THE PHYSICIAN WAS USING THIS CATHETER WITH A COIL, BUT FOUND THAT THE COIL COULD NOT BE MOVED FROM THE PROXIMAL PORTION OF THE CATHETER. THE PHYSICIAN THEN EMPLOYED A COIL PUSHER TO FACILITATE THE COIL MOVEMENT, BUT THE COIL STILL REMAINED JAMMED CATHETER. THE X-RAY SHOWED THAT, THE COIL HAD BECOME JAMMED IN THE GAP OF THE CATHETER HUB, PREVENTING THE COIL FROM BEING DEPLOYED. THE PHYSICIAN THEN OBTAINED ANOTHER RENEGADE DEVICE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE AFFECT ON THE PATIENT AS A RESULT OF THE REPORTED MALFUNCTION. ONE OTHER DEVICE WAS ALSO USED IN THIS PATIENT PROCEDURE; PLEASE REFERENCE ATTACHED MEDWATCH REPORT NUMBER 6000125-200-000XX, WHICH DOCUMENTS THAT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEGADE KRA KRA BOSTON SCIENTIFIC CORK NA 9225386

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR IDC DETACHABLE COIL, CAT # 3120220, LOT: 6145401