BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 10572274 · Received September 23, 2020

    Report

    Report Number
    9681834-2020-00190
    Event Type
    Injury
    Date Received
    September 23, 2020
    Date of Event
    September 8, 2020
    Report Date
    September 23, 2020
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER - REQUESTED, NOT PROVIDED. AGE & DATE OF BIRTH - REQUESTED, NOT PROVIDED. PATIENT SEX - REQUESTED, NOT PROVIDED. WEIGHT - REQUESTED, NOT PROVIDED. ETHNICITY - REQUESTED, NOT PROVIDED. RACE - REQUESTED, NOT PROVIDED. LOT NUMBER: REQUESTED, NOT PROVIDED. 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)- K122590, 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. REPRODUCTIVE TESTING WAS PERFORMED AND A GUIDEWIRE WAS WITHDRAWN FROM A METAL NEEDLE. AS A RESULT, THE URETHANE OUTER LAYER OF THE GUIDEWIRE WAS PEELED OFF. THE CROSS SECTION SURFACE OF THE URETHANE WAS SMOOTH AS IF IT HAD BEEN CUT WITH A BLADE, AND EXPOSED CORE WIRE WAS OBSERVED. 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 RECORD. IT IS LIKELY THAT ACTUAL GUIDEWIRE WAS EXPOSED TO A PULLING LOAD IN THE WITHDRAWAL DIRECTION WHILE ITS URETHANE COATING WAS IN CONTACT WITH THE METAL NEEDLE, RESULTING IN THE PEELING OF URETHANE OUTER LAYER. HOWEVER, WITH NO RETURN OF THE ACTUAL DEVICE, 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.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE INVOLVED RADIFOCUS GUIDEWIRE M WAS USED DURING THE PROCEDURE. PTCD DRAINAGE PROCEDURE ON (B)(6). AN ELASTER NEEDLE WAS NOT ENOUGH IN LENGTH AND WAS EXCHANGED TO A LONGER NEEDLE. AFTER THAT, A GUIDE WIRE WAS INSERTED, THEN DILATATION WITH A DILATOR WAS DONE, THEN A PIG DRAINAGE TUBE WAS INSERTED, AND THE PROCEDURE WAS COMPLETED. THEY TOOK A CT ON (B)(6), THEY NOTICED THAT A WHITE OBJECT WAS VISIBLE. LOOKING BACK AT THE CINE IMAGE, THEY COULD SEE ONLY ONE GUIDEWIRE AT FIRST, BUT TWO GUIDEWIRES BECAME THINLY VISIBLE AT SOME POINT ON THE WAY. THEY STATED THAT THE GUIDEWIRE MAY HAVE BEEN SCRATCHED WITH THE FIRST ENTRY NEEDLE AND SHEARED WHEN THE DRAINAGE TUBE WAS INSERTED. THE SHEARED FRAGMENT REMAINED IN THE BODY. FOLLOW-UP WILL BE CONTINUED SINCE RETRIEVAL OF THE FRAGMENT IS IMPOSSIBLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE HAS BEEN NO PATIENT HEALTH DAMAGE SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036503 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NEEDLE