BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDEWIRE M

    MDR report key: 7210243 · Received January 22, 2018

    Report

    Report Number
    9681834-2017-00278
    Event Type
    Injury
    Date Received
    January 22, 2018
    Date of Event
    December 27, 2017
    Report Date
    January 22, 2018
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G5: 510K - K923607,K926214,K151471,K152740 THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. WITH NO RETURN OF THE ACTUAL SAMPLE TO EVALUATE AND THE UNAVAILABILITY OF THE LOT NUMBER, THE INVESTIGATION FOR THIS COMPLAINT WAS LIMITED. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. WITH NO DEVICE RETURN THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD. 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 A RESIDUAL SUBSTANCE WAS FOUND IN THE X-RAY IMAGE OF THE PATIENT WHO HAD RECEIVED THE OPERATION FOR SIALOLITHIASIS. IT WAS REPORTED THAT THE ACTUAL SAMPLE WAS USED IN COMBINATION WITH AN ENDOSCOPE AND WITH A METALLIC TORQUE DEVICE. THE PROCEDURE OUTCOME IS UNKNOWN. THE RESIDUAL SUBSTANCE IS PLANNED TO BE EXTRACTED FROM THE PATIENT ON (B)(6) 2018.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO CORRECT THE 510K NUMBERS THAT WAS REPORTED IN THE INITIAL REPORT. IN THE INITIAL REPORT, THE FOLLOWING WAS DOCUMENTED 510K - K923607,K926214,K151471,K152740. THE CORRECT 510K NUMBERS ARE THE FOLLOWING: 510K - K923607,K926214.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54365 RADIFOCUS GLIDEWIRE M GUIDEWIRE CATHETER DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ENDOSCOPE| METALLIC TORQUE DEVICE| ENDOSCOPE| METALLIC TORQUE DEVICE