BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 8041247 · Received November 6, 2018

    Report

    Report Number
    9681834-2018-00197
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    October 10, 2018
    Report Date
    November 6, 2018
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G5: 510(K): K923607 AND K926214 THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION DID NOT REVEAL ANY ANOMALIES. MAGNIFYING INSPECTION REVEALED: ON APPROXIMATELY 300 - 700MM AND 755 - 1000MM FROM THE DISTAL END, THE URETHANE OUTER LAYER HAD BEEN ABRADED, ON APPROXIMATELY 745 - 750MM THE URETHANE OUTER LAYER HAD BEEN SHEARED OFF. THE OUTSIDE DIAMETER WAS MEASURED ON THE UNDAMAGED SECTION AND VERIFIED TO MEET THE SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT/LOT# COMBINATION CONFIRMED THAT THERE WERE NO FINDINGS. IFU STATES: IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIRE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE GUIDE WIRE'S TIP, DAMAGE TO THE CATHETER, OR DAMAGE TO THE CATHETER OR DAMAGE TO THE VESSEL. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. BASED ON THE INVESTIGATION RESULT, IT IS LIKELY THAT THE ACTUAL DEVICE CAME INTO CONTACT WITH SOME HARD OBJECT, WITH WHICH THE URETHANE OUTER LAYER WAS ABRADED AND SHEARED, DURING AN ATTEMPT TO COMBINE IT WITH THE INVOLVED CATHETER, THE CUSTOMER PERCEIVED ROUGHNESS ON THE ACTUAL DEVICE. HOWEVER, WITH THE ABSENCE OF THE INFORMATION ABOUT THE DEVICES INVOLVED IN THIS PROCEDURE, INCLUDING THE INVOLVED CATHETER, OR WITH NO DETAILED INFORMATION ABOUT THE EVENTS LEADING UP TO THE REPORTED EVENT, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE WHEN THE CUSTOMER TRIED TO COMBINE THE PRIMED RADIFOCUS GUIDEWIRE M SAMPLE WITH THE INVOLVED CATHETER, HE OBSERVED A ROUGH FEELING ON ITS SURFACE AND DECIDED NOT TO USE IT. THE PROCEDURE OUTCOME WAS REPORTED TO BE UNKNOWN. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882190 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 180706

    Patients

    Seq Age Sex Outcome Treatment
    1