BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE ADVANTAGE

    MDR report key: 10940800 · Received December 3, 2020

    Report

    Report Number
    9681834-2020-00241
    Event Type
    Malfunction
    Date Received
    December 3, 2020
    Date of Event
    October 18, 2020
    Report Date
    December 3, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE

    Narratives

    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 SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE ACTUAL SAMPLE REVEALED THAT IN THE SECTION 0 - 10MM FROM THE DISTAL END, THE URETHANE COAT WAS MISSING, AND THE CORE WIRE WAS EXPOSED. THE SECTION APPROXIMATELY 25 MM - 30 MM FROM THE DISTAL END HAD BEEN CURVED. MAGNIFYING INSPECTION REVEALED THAT THE DISTAL END OF THE URETHANE COAT HAD BEEN ELONGATED AND THE GOLD COIL HAD BEEN UNRAVELED. ELECTRON MICROSCOPIC INSPECTION OF THE DISTAL END OF THE URETHANE COAT REVEALED THAT THE SHAPE OF THE DISTAL END INDICATING THAT IT HAD BEEN PULLED AND TORN, SOME CREASES NEAR THE DISTAL END, ELONGATION OF URETHANE COAT. ELECTRON MICROSCOPIC INSPECTION OF THE CORE WIRE REVEALED THAT THE DISTAL END HAD A SHAPE INDICATING THAT IT HAD BEEN CUT THROUGH A SIZING CUT EQUIPMENT DURING PRODUCTION. IT IS CONCEIVABLE THAT THERE WAS NO MISSING SECTION IN THE CORE WIRE. THE OUTER DIAMETER OF THE INTACT AREA ON THE URETHANE-COATED SECTION WAS MEASURED AND CONFIRMED TO MEET THE CONTROL CRITERIA. REPRODUCTIVE TESTING WAS PERFORMED BY PULLING OUT A GUIDEWIRE SAMPLE FROM A HOLDER TUBE WITH A CLIP HUB STILL ATTACHED TO THE HOLDER TUBE. AS A RESULT; THE URETHANE COAT WAS FRACTURED. EXPOSURE OF THE CORE WIRE AND GOLD COIL WAS OBSERVED. UNRAVELING OF THE GOLD COIL WAS OBSERVED. THE FRACTURED END OF THE URETHANE COAT HAD A SHAPE THAT IT HAD BEEN PULLED AND TORN. SOME CREASES WERE OBSERVED. ELONGATION OF URETHANE COAT WAS OBSERVED. THESE STATES SEEMED TO BE SIMILAR TO THOSE OBSERVED ON THE ACTUAL SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. IT IS LIKELY THAT THE ACTUAL SAMPLE WAS EXPOSED TO SOME KIND OF TENSILE LOAD, AND THE URETHANE COATING WAS TORN AND SEPARATED FROM THE CORE WIRE. THE REPRODUCTIVE TEST RESULT INDICATES THAT THIS FRACTURE MODE MAY OCCUR WHEN A GUIDEWIRE IS PULLED OUT FROM A HOLDER TUBE WITH THE CLIP HUB STILL ATTACHED TO THE HOLDER TUBE. HOWEVER, 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.

    Description of Event or Problem · 1

    THIS REPORT HAS BEEN DEEMED REPORTABLE BASED UPON THE EVALUATION OF THE ACTUAL DEVICE. THE USER FACILITY REPORTED THAT THE ACTUAL RADIFOCUS GLIDEWIRE ADVANTAGE WAS USED PRE-TREATMENT. WHEN THE PRODUCT WAS OPENED, THE DISTAL PART OF THE PRODUCT DID NOT HAVE THE HYDROPHILIC MATERIAL. THE PRODUCT WAS NOT USED. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1405704 RADIFOCUS GLIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 190719

    Patients

    Seq Age Sex Outcome Treatment
    1