BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS OPTITORQUE

    MDR report key: 14682087 · Received June 13, 2022

    Report

    Report Number
    9681834-2022-00112
    Event Type
    Malfunction
    Date Received
    June 13, 2022
    Report Date
    June 13, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K082736
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UDI - N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K): K082736 K992051 K150232. THE ACTUAL SAMPLE WAS NOT RETURNED TO ASHITAKA FACTORY, THE INVESTIGATION OF IT WAS UNABLE TO BE PERFORMED. REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION CONFIRMED THAT THERE WERE NOT ANY INDICATIONS OF ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION FROM OTHER FACILITIES. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. SINCE THE ACTUAL PRODUCT WAS NOT RETURNED AND THE DETAILS OF OCCURRENCE SITUATION WERE UNKNOWN, THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE DIAGNOSTIC CATHETER JE3.5 FR 100CM, LOT 190708, BENT WHEN REMOVING THE PACKAGING. THERE WAS DIFFICULTY IN PASSING THE GUIDEWIRE THROUGH ITS LUMEN. THERE WAS A FRACTURE OF THE MATERIAL BEFORE THE ENDS OF THE CATHETER REACHED THE TRUNK BRACHIOCEPHALIC (CATHETER FRACTURE WITH FRAGMENT AT THE END NEAR THE MANIFOLD). THE EVENT OCCURRED INTRA-OPERATIVE. THE PATIENT DID NOT REQUIRE MEDICAL OR SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1582911 RADIFOCUS OPTITORQUE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 190708

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown