BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI GRANDSLAM PTCA GUIDE WIRE

    MDR report key: 4658652 · Received April 3, 2015

    Report

    Report Number
    3003775027-2015-00029
    Event Type
    Malfunction
    Date Received
    April 3, 2015
    Date of Event
    January 1, 2015
    Report Date
    March 11, 2015
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K031277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE ANALYSIS WAS PERFORMED BY ASAHI INTECC. CO. LTD: THE DEVICE WAS NOT RETURNED FOR OUR INVESTIGATION. WITH THE PROVIDED INFORMATION, IT IS PRESUMED THAT THERE OCCURRED SOME ACCIDENTAL, INAPPROPRIATE CONTACT BETWEEN THE ATHERECTOMY DEVICE AND THE GRAND SLAM GUIDEWIRE, RESULTING IN THE DAMAGE TO THE PTFE COATING OF THE GUIDEWIRE. ALL THE SHIPPED PRODUCTS ARE INSPECTED IN THE PRODUCTION PROCESS FOR MEETING THE PRODUCT SPECIFICATIONS AND RELEASE CRITERIA, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE WARNING SECTION OF THE INSTRUCTIONS FOR USE (IFU) DESCRIBES: IF ANY RESISTANCE IS FELT DUE TO SPASM OR THE GUIDEWIRE BEING BENT OR TRAPPED WHILE OPERATING THE GUIDEWIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT MOVE OR TORQUE THE GUIDEWIRE. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDE WIRE IS MOVED EXCESSIVELY IT MAY BREAK OR BECOME DAMAGED, RESULTING IN FRAGMENTS BEING LEFT INSIDE THE VESSEL. SEPARATION OR BREAKAGE OF GUIDEWIRE IS LISTED AS A POSSIBLE COMPLICATION AND ADVERSE EVENT. THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, (B)(4) DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE 300 CM STRAIGHT GRANDSLAM GUIDE WIRE IN A PERIPHERAL PROCEDURE WITH AN ATHERECTOMY DEVICE, THE COATING WAS NOTED TO BE CRINKLING OR PEELING FROM THE GUIDE WIRE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223001 ASAHI GRANDSLAM PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI

    Patients

    Seq Age Sex Outcome Treatment
    1 ATHERECTOMY: BSCI JETSTREAM PATHWAYS