BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDEWIRE ADVANTAGE

    MDR report key: 10377882 · Received August 7, 2020

    Report

    Report Number
    9681834-2020-00160
    Event Type
    Injury
    Date Received
    August 7, 2020
    Date of Event
    July 8, 2020
    Report Date
    August 7, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. MECHANISM OF THE GUIDEWIRE FRACTURE: BASED ON THE PREVIOUS REPRODUCTIVE TEST RESULTS, TERUMO ASHITAKA FACTORY IS AWARE THAT THE GUIDE WIRE MAY BECOME FRACTURED WHEN IT HAS BEEN SUBJECTED TO ONE OF THE FOLLOWING LOADS, AND THE FRACTURE SECTION OF THE CORE WIRE PRESENTS SOME REGULARITY DEPENDING ON THE LOAD THE GUIDE WIRE HAS BEEN SUBJECTED TO: WHEN A GUIDEWIRE IS SUBJECTED TO AN EXCESSIVE PULLING LOAD IN ONE DIRECTION, THE FRACTURE END OF THE CORE WIRE DEFORMS IN A TAPERED SHAPE; WHEN A PULLING LOAD IS APPLIED TO A GUIDEWIRE KEPT IN A LOOP SHAPE, THE FRACTURE END DEFORMS IN A CURVE SHAPE; WHEN A GUIDEWIRE IS SUBJECTED TO EXCESSIVELY REPETITIVE BENDING LOAD AT 90-DEGREE ANGLE, DIMPLE PATTERN IS OBSERVED ON THE FRACTURE SURFACE OF THE CORE WIRE; WHEN A ONE-WAY TORQUE LOAD IS APPLIED TO A GUIDEWIRE KEPT IN A CURVED SHAPE, RADIAL PATTERN IS OBSERVED ON THE FRACTURE SURFACE OF THE CORE WIRE. BASED ON THE DESCRIPTION OF THE EVENT, IT WAS LIKELY THAT THE ACTUAL PRODUCT WAS EXPOSED TO AN EXCESSIVE PULLING LOAD WHILE BEING TRAPPED IN THE CALCIFIED LESION, WHICH RESULTED IN THE TIP SECTION GETTING SEVERED. HOWEVER, WITH NO RETURN OF THE ACTUAL DEVICE THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    UDI: NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K)- K122590, K163004. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORD AND SHIPPING INSPECTION RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE INVOLVED RADIFOCUS GLIDEWIRE ADVANTAGE WAS USED DURING THE PROCEDURE. THE WIRE BECAME STUCK IN THE CALCIFICATION. THE WIRE TIP THEN BECAME TORN. THE COILED PART OF THE WIRE DETACHED FROM SHAFT AND WAS PULLED APART, DURING PULL BACK OF THE WIRE. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842771 RADIFOCUS GLIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 191223

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other