BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 8611297 · Received May 15, 2019

    Report

    Report Number
    9681834-2019-00079
    Event Type
    Malfunction
    Date Received
    May 15, 2019
    Report Date
    May 15, 2019
    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 · 0

    DATE OF EVENT: (B)(6) 2018 PROVIDED. UDI - NOT REQUIRED FOR THE REPORTED PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 510(K): K923607 AND K926214. (B)(4). THE INVOLVED DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE INVESTIGATION WAS BASED ON USER FACILITY INFORMATION AND EVALUATION OF THE PRODUCT SAMPLES. REPRODUCTIVE TESTING WAS PERFORMED. A PRODUCT SAMPLE WAS SUBJECTED TO REPETITIVE BENDING FORCE AT A 90-DEGREE ANGLE UNTIL IT BECAME FRACTURED. SUBSEQUENT ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURE REVEALED THAT THE FRACTURE CROSS SECTION HAD A DIMPLE PATTERN WITH NO DIMINISHMENT OF THE OUTSIDE DIAMETER TOWARD THE FRACTURE END. A PRODUCT SAMPLE WAS SUBJECTED TO REPETITIVE ONE-WAY TORQUE FORCE UNTIL IT BECAME FRACTURED. SUBSEQUENT ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURE REVEALED THE GENERATION OF A RADIAL PATTERN ON THE FRACTURE CROSS-SECTION SURFACE. A PRODUCT SAMPLE WAS SUBJECTED TO ONE-WAY PULLING FORCE UNTIL IT BECAME FRACTURED. SUBSEQUENT ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURE REVEALED THE OUTSIDE DIAMETER OF THE WIRE HAD BEEN DIMINISHED TOWARD THE FRACTURE END. A PRODUCT SAMPLE WAS SUBJECTED TO PULLING FORCE IN THE STATE OF BEING FORMED INTO A LOOP-LIKE SHAPE UNTIL IT BECAME FRACTURED. SUBSEQUENT ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURE REVEALED THE EDGE OF THE FRACTURE WAS IN THE CURVED SHAPE. A REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT /LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. 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, AND SEPARATION OF THE GUIDE WIRE'S TIP, DAMAGE TO THE CATHETER, OR DAMAGE TO THE VESSEL. BASED ON THE INVESTIGATION OF THE PRODUCT SAMPLES, IT IS LIKELY THAT THE ACTUAL SAMPLE WAS EXPOSED TO FORCE, RESULTING IN THE REPORTED EVENT. HOWEVER, WITH NO DEVICE RETURN 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. EXEMPTION NUMBER E2015022.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A SHUNT PTA, THE DISTAL SECTION OF THE ACTUAL RADIFOCUS GUIDEWIRE M SUDDENLY FRACTURED OFF IN THE BODY WITH NO RESISTANCE PERCEIVED. THE FRAGMENT WAS RETRIEVED FROM THE BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405637 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 180703

    Patients

    Seq Age Sex Outcome Treatment
    1