BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANALIZER STANDARD ANGLED

    MDR report key: 1936030 · Received December 9, 2010

    Report

    Report Number
    9613246-2010-00003
    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 REPORTED PRODUCT CONFIRMED THE CUSTOMER'S REPORT. THERE WERE NO DEFECTS OR DEVIATIONS NOTED DURING THE BATCH RECORD REVIEW. BASED ON THE 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, E.G. AN INTRODUCER NEEDLE. 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 PART 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 POLYURETHANE JACKET OF THE GUIDEWIRE CAME OFF APPROX 10-15CM OF THE POLYURETHANE JACKET WAS LEFT IN THE PT. AN ADDITIONAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANALIZER STANDARD ANGLED CANALIZER GUIDE WIRE DQX PBN MEDICALS DENMARK A/S 127635180 P353527

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention