BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANALIZER STANDARD STRAIGHT

    MDR report key: 1936029 · Received December 9, 2010

    Report

    Report Number
    9613246-2010-00004
    Event Type
    Injury
    Date Received
    December 9, 2010
    Report Date
    December 3, 2010
    Manufacturer
    PBN MEDICALS DENMARK A/S
    Product Code
    DQX
    PMA / PMN Number
    K050873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF THE RETURNED PRODUCT CONFIRMED THE CUSTOMER'S REPORT. BASED ON EVAL OF THE RETURNED PRODUCT WE CONCLUDE THAT THE POTENTIAL REASON FOR THE DAMAGE TO THE PRODUCT IS A RESULT OF INCORRECT USE, POTENTIALLY FROM CONTACT WITH A SHARP DEVICE. 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 GUIDEWIRES 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."

    Description of Event or Problem · 1

    LIMITED INFO OBTAINED FROM COMPLAINANT. DURING A VASCULAR PROCEDURE USING A CANALIZER GUIDE WIRE PRODUCT, CUSTOMER STATES THAT THE GUIDEWIRE GOT STUCK IN THE CATHETER DUE TO DAMAGES TO THE POLYURETHANE JACKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANALIZER STANDARD STRAIGHT CANALIZER DQX PBN MEDICALS DENMARK A/S 125135150 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention