BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS INTRODUCER

    MDR report key: 14427348 · Received May 18, 2022

    Report

    Report Number
    9681834-2022-00090
    Event Type
    Injury
    Date Received
    May 18, 2022
    Date of Event
    April 19, 2022
    Report Date
    May 17, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DYB
    PMA / PMN Number
    K033681
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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) - K062858, K082644. DEVICE MANUFACTURE DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER THE ACTUAL SAMPLE WAS RETURNED FOR PRODUCT EVALUATION. A MINI GUIDE WIRE ONLY WAS RETURNED AS THE ACTUAL SAMPLE. VISUAL INSPECTION OF THE ACTUAL SAMPLE FOUND THAT THE DISTAL END HAD BEEN FRACTURED AND THE CORE WIRE WAS EXPOSED. THE MISSING LENGTHS OF THE CORE WIRE AND THE OUTER LAYER WERE APPROXIMATELY 4 MM AND 5 MM RESPECTIVELY. MAGNIFYING INSPECTION OF THE FRACTURED AREA FOUND THAT THE OUTER LAYER HAD BEEN DEFORMED IN TAPER SHAPE. ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURED AREA FOUND THAT THE EDGE OF THE OUTER LAYER WAS IN TORN-LIKE SHAPE. IT WAS INFERRED THAT THE ACTUAL SAMPLE WAS EXPOSED TO A PULLING LOAD AND FRACTURED. ELECTRON MICROSCOPE INSPECTION OF THE EXPOSED PART OF THE CORE WIRE FOUND THAT THE CORE WIRE HAD BEEN CURVED AND TAPERED, AND DIMPLE PATTERN WAS OBSERVED ON THE FRACTURE SURFACE. THE OUTER DIAMETER OF THE ACTUAL SAMPLE WAS MEASURED NEAR THE FRACTURE AND CONFIRMED TO MEET THE FACTORY'S CONTROL STANDARDS. SIMULATION TEST/MECHANISM OF THE FRACTURE OF GUIDEWIRE. IT IS KNOWN FROM OUR PAST EXPERIMENTS THAT THE GUIDEWIRE MAY GET FRACTURED WHEN IT HAS BEEN SUBJECTED TO ONE OF THE LOADS DESCRIBED BELOW, IN ADDITION, THE FRACTURED END OF CORE WIRE PRESENTS SOME REGULARITY DEPENDING ON THE FRACTURE MECHANISM. FRACTURE DUE TO PULLING LOAD TO A CURVED GUIDEWIRE. THE FRACTURED END IS CURVED AND TAPERED, AND DIMPLE PATTERN IS OBSERVED ON THE FRACTURE SURFACE. THIS STATE IS SIMILAR TO THAT OF THE ACTUAL SAMPLE. FRACTURE DUE TO REPEATED BENDING LOAD AT A 90-DEGREE ANGLE. THE FRACTURED END IS NOT TAPERED OR CURVED, BUT DIMPLE PATTERN IS OBSERVED ON THE FRACTURE SURFACE. IT IS PRESUMED THAT THE ACTUAL SAMPLE WAS NOT FRACTURED BY THIS MECHANISM. FRACTURE DUE TO A CONTINUOUS ONE-WAY TORQUE LOAD TO A TEST SAMPLE KEPT IN A CURVE SHAPE. THE FRACTURED END IS NOT TAPERED OR CURVED, BUT RADIAL PATTERN IS OBSERVED ON THE FRACTURE SURFACE. IT IS PRESUMED THAT THE ACTUAL SAMPLE WAS NOT FRACTURED BY THIS MECHANISM. FRACTURE DUE TO ONE-WAY PULLING LOAD . THE FRACTURED END IS DEFORMED IN TAPER SHAPE. FROM THIS, IT IS PRESUMED THAT THE ACTUAL SAMPLE WAS NOT FRACTURED BY THIS MECHANISM. SINCE THE INVOLVED LOT NUMBER WAS UNKNOWN, REVIEW OF MANUFACTURING HISTORY RECORDS OR COMPLAINT RECORDS COULD NOT BE PERFORMED. FROM THE RESULTS OF THE INVESTIGATION, IT WAS LIKELY THAT THE ACTUAL SAMPLE WAS EXPOSED TO A PULLING LOAD WHILE IT WAS CURVED, WHICH RESULTED IN THE FRACTURE OF THE TIP. HOWEVER, SINCE THE DETAILS OF THE PROCEDURE WAS UNKNOWN, THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. IFU STATES: "DO NO RESHAPE THE TIP OF THE MINI GUIDE WIRE." (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT AFTER PUNCTURING, IN ORDER TO USE A SHEATH THEY ATTEMPTED TO INSERT A MINI GUIDEWIRE INTO A PLASTIC CANNULA AS USUAL, AND NOTICED THAT THE MINI GUIDEWIRE TIP WAS FRACTURED. THE MINI GUIDEWIRE HAD JUST BEEN REMOVED FROM THE PACKAGE TRAY AS USUAL, AND NOTHING PARTICULAR HAD BEEN DONE TO IT. THEREFORE, THEY DETERMINED THAT THE PRODUCT WAS DEFECTIVE, REPLACED THE PRODUCT, AND COMPLETED THE PROCEDURE. UPON INSPECTION THEY FOUND FEELING OF URETHANE. FRAGMENT WAS NOT RETURNED AND POSSIBLY REMAINED IN THE PATIENT. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2605898 RADIFOCUS INTRODUCER INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other