BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 11854063 · Received May 20, 2021

    Report

    Report Number
    9681834-2021-00082
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    April 27, 2021
    Report Date
    May 20, 2021
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER: REQUESTED, NOT PROVIDED. EXPIRATION DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K)- K923607, K926214. DEVICE MANUFACTURER DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE ACTUAL SAMPLE CONFIRMED THAT IT HAD BEEN FRACTURED INTO TWO PIECES DISTAL FRAGMENT AND MAIN BODY. THE FRACTURE WAS FOUND OCCURRED AT APPROXIMATELY 30 MM FROM THE DISTAL END. THE LENGTH OF BOTH PARTS WAS MEASURED; THE DISTAL FRAGMENT WAS APPROXIMATELY 30 MM IN LENGTH AND THE MAIN BODY WAS APPROXIMATELY 970 MM IN LENGTH. AS THE TOTAL LENGTH OF BOTH PARTS WAS EQUIVALENT TO THAT OF A CURRENT PRODUCT, WHICH WAS APPROXIMATELY 1000 MM IN LENGTH, IT WAS JUDGED THAT THERE WAS NO PORTION MISSING FROM THE ACTUAL SAMPLE. MAGNIFYING INSPECTION OF THE FRACTURE END OF THE DISTAL FRAGMENT FOUND THAT THE URETHANE COAT SEEMED TO HAVE BEEN PULLED AND TORN OFF. ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURE END OF THE DISTAL FRAGMENT FOUND MULTIPLE CREASES ON THE URETHANE COAT. MAGNIFYING INSPECTION OF THE FRACTURE END OF THE MAIN BODY FOUND THAT THE URETHANE COAT SEEMED TO HAVE BEEN PULLED AND TORN OFF. ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURE END OF THE MAIN BODY FOUND MULTIPLE CREASES ON THE URETHANE COAT. THE CORE WIRE WAS INSPECTED UNDER AN ELECTRON MICROSCOPE. THE FRACTURE ENDS OF BOTH PIECES HAD BEEN CURVED. THE FRACTURE SURFACES OF THE CORE WIRE OF BOTH PIECES WERE INSPECTED UNDER AN ELECTRON MICROSCOPE. THE FRACTURE SURFACES WERE FOUND ROUGH. THE OUTER DIAMETER OF THE ACTUAL SAMPLE WAS MEASURED AND CONFIRMED TO MEET THE FACTORY'S CONTROL CRITERIA AND NO ANOMALY WAS OBSERVED. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD AND SHIPPING INSPECTION RECORDS. MECHANISM OF THE GUIDEWIRE FRACTURE: BASED ON THE PREVIOUS REPRODUCTIVE TEST RESULTS, THE GUIDE WIRE MAY GET FRACTURED WHEN IT HAS BEEN SUBJECTED TO ONE OF THE LOADS DESCRIBED BELOW, AND THE FRACTURE SURFACE OF THE CORE WIRE PRESENTS SOME REGULARITY DEPENDING ON THE LOAD THE GUIDE WIRE HAS BEEN SUBJECTED TO. PULLING LOAD TO THE TEST SAMPLE KEPT IN A LOOP SHAPE. THE FRACTURE END BECOMES CURVED AND THE FRACTURE SURFACE IS ROUGH. THE FRACTURE STATE WAS FOUND SIMILAR TO THAT OF THE ACTUAL SAMPLE. REPETITIVE BENDING LOAD AT A 90-DEGREE ANGLE. ONE-WAY TORQUE LOAD TO A TEST SAMPLE KEPT IN A CURVED SHAPE. THE FRACTURE END IS FLAT AND RADIAL PATTERN IS OBSERVED ON THE FRACTURE SURFACE. IT WAS PRESUMED THAT THE ACTUAL SAMPLE WAS NOT FRACTURED BY THIS MECHANISM. ONE-WAY PULLING LOAD. THE FRACTURE END IS NOT FLAT AND DIMPLE PATTERN IS OBSERVED ON THE FRACTURE SURFACE. THIS STATE IS DIFFERENT FROM THAT OBSERVED IN THE ACTUAL SAMPLE. IT WAS PRESUMED THAT THE ACTUAL SAMPLE WAS NOT FRACTURED BY THIS MECHANISM. 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 VESSEL. 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 CORE WIRE WAS FRACTURED BY METAL FATIGUE DUE TO EXCESSIVE TENSILE LOAD APPLIED WHILE THE DISTAL TIP OF THE ACTUAL SAMPLE WAS KEPT IN LOOP, AND THEN THE URETHANE COAT WAS PULLED AND TORN OFF BY THE LOAD DURING SUBSEQUENT OPERATION AND REMOVAL. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4) .

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WHEN THE RADIFOCUS GUIDEWIRE M WAS BEING INSERTED INTO THE MEDIKIT 4FR ANGIOGRAPHIC CATHETER, IT BECAME STUCK AND DID NOT PASS THROUGH PROPERLY. THE GUIDEWIRE AND THE CATHETER WERE REMOVED TOGETHER FROM THE BODY, AND THEN RE-INSERTED BUT IT WOULD NOT GO THROUGH PROPERLY. WHEN THE GUIDEWIRE WAS REMOVED, IT WAS FOUND UNDER FLUOROSCOPY THAT THE GUIDEWIRE TIP WAS MISSING. THE TIP WAS FOUND DROPPED ON THE DRAPE. IT WAS CONFIRMED UNDER FLUOROSCOPY THAT NO FRAGMENT WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753236 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1