BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANALIZER STIFF ANGLED

    MDR report key: 1883059 · Received October 15, 2010

    Report

    Report Number
    9613246-2010-00002
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 16, 2010
    Report Date
    October 14, 2010
    Manufacturer
    PBN MEDICALS DENMARK A/S
    Product Code
    DQX
    PMA / PMN Number
    K050873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF THE RETURNED PRODUCT CONFIRMED THE CUSTOMER'S REPORT. IN ORDER TO EXPLAIN THE DAMAGES DONE TO THE GUIDEWIRE, ADDITIONAL INFO HAS BEEN REQUESTED FROM THE CUSTOMER. THERE WERE NO DEFECTS OR DEVIATIONS NOTED DURING THE BATCH RECORD REVIEW. OUR IFU STATES "CAUTION: DO NOT USE THE GUIDEWIRE WITH DEVICES THAT CONTAIN METAL PARTS, SUCH AS ATHERECTOMY CATHETER OR METAL INTRODUCING DEVICES. USE WITH DEVICES THAT CONTAIN METAL PARTS MAY CAUSE DAMAGE AND/OR ABRASION OF THE HYDROPHILIC COATING. TO PREVENT DAMAGE TO THE VASCULATURE AND GUIDEWIRE AND BREAKAGE/SEPARATION/CUTTING OF THE CATHETER, ALWAYS MANIPULATE CAREFULLY AND SLOWLY WHILE CONFIRMING THE MOTION AND LOCATION OF THE GUIDEWIRE TIP UNDER FLUOROSCOPY. DURING MANIPULATION, IF ANY RESISTANCE IS FELT OR IF THERE APPEARS TO BE ANY PROBLEMS WITH THE GUIDEWIRE'S TIP, STOP THE MANIPULATION AND FIND OUT THE CAUSE WITH THE FLUOROSCOPY. CONTINUING A MANIPULATION AFTER A PROBLEM HAS BEEN DETECTED MIGHT CAUSE DAMAGE TO THE VASCULATURE, BREAKAGE/SEPARATION/CUTTING OF THE GUIDEWIRE AND/OR DAMAGE TO THE CATHETER. A RETRIEVING DEVICE, SUCH AS GRIPPERS AND BASKET FORCEPS SHOULD ONLY BE USED AFTER THE GUIDEWIRE MANIPULATING IS FINISHED AND THE GUIDEWIRE HAS BEEN REMOVED FROM THE PT'S VASCULATURE. USING SUCH DEVICES COULD TEAR OR BREAK THE GUIDEWIRE, AND/OR DAMAGE THE HYDROPHILIC COATING."

    Description of Event or Problem · 1

    DURING PROCEDURE, THE CANALIZER GUIDEWIRE GOT STUCK IN THE CATHETER WHILE THE CANALIZER GUIDEWIRE WAS WITHDRAWN FROM THE CATHETER. PIECES OF THE CANALIZER GUIDEWIRE POLYURETHANE JACKET WERE LOOSENED FROM THE INNER NITINOL CORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANALIZER STIFF ANGLED GUIDE WIRE DQX PBN MEDICALS DENMARK A/S 129735260 P363800

    Patients

    Seq Age Sex Outcome Treatment
    1 Other