BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE ADVANTAGE

    MDR report key: 20723647 · Received November 19, 2024

    Report

    Report Number
    9681834-2024-00203
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    September 12, 2024
    Report Date
    November 19, 2024
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: N/A AT THIS PRODUCT CODE IS NOTE EXPORTED TO THE US MARKET. G4: 510(K): K122590, K163004. VISUAL INSPECTION (UNAIDED EYE AND DIGITAL MICROSCOPE): NO SIGNS OF FRACTURE WERE FOUND ALONG THE ENTIRE LENGTH OF THE ACTUAL SAMPLE. PEELING OF URETHANE LAYER WAS FOUND AT APPROXIMATELY 155-170 MM FROM THE DISTAL END. EXPOSURE OF CORE WIRE WAS OBSERVED AT APPROXIMATELY 170 MM FROM THE DISTAL END. AT APPROXIMATELY 175 MM FROM THE DISTAL END, M-COAT HAD BEEN PEELED, AND THE URETHANE LAYER WAS SLIGHTLY FLOATED. ABRASIONS WITH PEELING OF M-COAT WAS OBSERVED IN THE AREA APPROXIMATELY 195 MM - 205 MM FROM THE DISTAL END. EXPOSURE OF CORE WIRE OVER THE ENTIRE CIRCUMFERENCE WAS OBSERVED AT APPROXIMATELY 200 MM FROM THE DISTAL END. NO APPEARANCE ANOMALY WAS FOUND IN THE OTHER PARTS. VISUAL INSPECTION (ELECTRON MICROSCOPE): THERE WERE CREASES AND TORN-LIKE SHAPES OBSERVED IN THE DAMAGED AREAS THAT ARE LISTED. DIMENSIONS: THE OUTER DIAMETER OF THE HYDROPHILIC COAT AND THE PTFE-COAT SECTIONS MET THE FACTORY'S CONTROL STANDARDS, AND NO ANOMALIES WERE OBSERVED. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO OTHER SIMILAR REPORT WAS FOUND IN THE PAST COMPLAINT FILE. THE INVESTIGATION RESULT REVEALED NO ANOMALY IN THE MANUFACTURING HISTORY RECORDS AND THE DIMENSIONS OF THE UNDAMAGED PART OF THE ACTUAL SAMPLE. ONE POSSIBILITY IN THIS CASE WAS INFERRED THAT THE OUTER DIAMETER BECAME THICKER DUE TO THE PEELING OF THE URETHANE LAYER, WHICH COULD HAVE RESULTED IN THE REPORTED RESISTANCE. AS A CAUSE OF THE PEELING OF URETHANE LAYER, THE FOLLOWING MECHANISM WAS INFERRED. ABRASIONS WERE CAUSED TO THE URETHANE LAYER DUE TO CONTACT WITH A HARD OBJECT. A PULLING LOAD WAS APPLIED TO THE INVOLVED AREA, LEADING TO THE STRETCHING AND PEELING OF THE URETHANE LAYER. HOWEVER, SINCE THE DETAILS OF THE PROCEDURE WERE UNKNOWN, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF THE OCCURRENCE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "THE RADIFOCUS GLIDEWIRE ADVANTAGE IS DESIGNED TO DIRECT A CATHETER TO THE DESIRED ANATOMICAL LOCATION DURING DIAGNOSTIC OR INTERVENTIONAL PROCEDURES, EXCEPT FOR THE HEART OR CENTRAL CIRCULATORY SYSTEM." "IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIRE ADVANTAGE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. CONTINUING TO MANIPULATE OR ROTATE THE GLIDEWIRE ADVANTAGE OR 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 VESSEL." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT A COMPLAINT WAS RECEIVED FROM THE CHEST SURGERY SERVICE, RELATED TO THE RADIFOCUS GLIDEWIRE ADVANTAGE DEVICE. THE PROCEDURE PERFORMED WAS A BRONCHOSCOPY. DURING THE BRONCHOSCOPY, AN ATTEMPT WAS MADE TO ADVANCE THE GUIDE THROUGH THE BRONCHOSCOPE. HOWEVER, IT DID NOT ADVANCE, AND RESISTANCE WAS FELT, THEREFORE, THE GUIDE WAS RETURNED. WHEN REMOVING IT, THE BURST RUBBER WAS OBSERVED, AND ANOTHER GUIDE WAS REQUESTED. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PROCURE OUTCOME WAS NOT PROVIDED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144558 RADIFOCUS GLIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RA*CA35185CM 231212

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown