BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 11632926 · Received April 8, 2021

    Report

    Report Number
    9681834-2021-00054
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 8, 2021
    Report Date
    April 8, 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

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. NAME- REQUESTED, NOT PROVIDED. PMA/510(K)- K926214. DEVICE MANUFACTURER DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORDS. 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 DESCRIPTION OF THE EVENT, IN ADDITION TO THE ACTUAL GUIDEWIRE, A BALLOON FROM ANOTHER BRAND WAS USED AND IT HAS NOT IDENTIFIED WHICH DEVICE HAD CONTRIBUTED THE PERFORATION. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. 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 · 1

    THE USER FACILITY REPORTED THAT THE RADIFOCUS GUIDEWIRE WAS USED DURING THE CRT-D IMPLANT PROCEDURE. DURING PREPARATORY MANIPULATION FOR THE INTRODUCTION OF A LEFT VENTRICULAR LEAD TO CORONARY SINUS, PERFORATION OF BLOOD VESSEL WAS CONFIRMED IN THE CORONARY SINUS. PERICARDIAL EFFUSION WAS NOT CONFIRMED BY ECHO AND NO CHANGES IN BP. NO TREATMENT HAS BEEN DONE TO THE PERFORATION. THE DEVICES WHICH HAD BEEN INSERTED IN THE CORONARY SINUS WERE EXTRACTED AND DISCARDED. THE LEFT VENTRICULAR LEAD PLACEMENT AND THE CRT-D IMPLANT HAVE BEEN SUSPENDED. NO DETERIORATION IN THE PATIENT CONDITION WAS BEEN REPORTED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533836 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR