BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDECATH

    MDR report key: 16235524 · Received January 24, 2023

    Report

    Report Number
    9681834-2022-00283
    Event Type
    Injury
    Date Received
    January 24, 2023
    Report Date
    January 24, 2023
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQO
    PMA / PMN Number
    K090040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE ADDITIONAL INFORMATION IN SECTION B5. THIS REPORT HAS BEEN DEEMED NOT REPORTABLE BASED UPON THE ADDITIONAL INFORMATION RECEIVED.

    Additional Manufacturer Narrative · 0

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 510K: K915414. SINCE THE LOT NUMBER WAS UNKNOWN, THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD COULD NOT BE REVIEWED. A SEARCH OF THE COMPLAINT FILE FOR PAST THREE YEARS FOUND NO OTHER SIMILAR REPORT OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE. THE FRACTURED PIECE THAT MAY REMAIN IN THE PATIENT'S BODY ARE SCHEDULED TO BE REMOVED BY ABDOMINAL OPERATION, AND THE REMOVED FRACTURED PIECE IS PLANNED TO BE OBTAINED. THEREFORE, THE ACTUAL SAMPLE WILL BE EVALUATED UPON ITS ARRIVAL AT ASHITAKA FACTORY. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO: (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF (B)(4) CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 27FEB2023: THE FRACTURED PIECE WAS NOT TERUMO'S HOWEVER WAS A COMPETITOR'S PRODUCT AND THE REPORTED COMPLAINT HAS BEEN CONFIRMED TO HAVE NOTHING TO DO WITH TERUMO'S PRODUCTS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT IT WAS POSSIBLE THAT THE ANGIOGRAPHY CATHETER WAS CAUGHT IN THE STENT STRUT OF AFX (JAPAN LIFELINE) AT THE TIME OF ENDOVASCULAR REPAIR OF ABDOMINAL ANEURYSM (EVAR), WAS FRACTURED, AND REMAINED IN THE INTERNAL ILIAC ARTERY. THE EVENT WAS UNNOTICED WHEN STENT-GRAFT PLACEMENT WAS PERFORMED 3 - 6 MONTHS EARLIER, AND THE CASE WAS FINISHED. THIS TIME, THE ANEURYSM WAS EXPANDING, AND WE NOTICED THAT THE CATHETER WAS REMAINED DURING THE TREATMENT OF TYPE II. AFTER CONFIRMING THE PRODUCTS USED IN THE PREVIOUS CASE, IT WAS FOUND THAT 4F GLIDECATH WAS PROBABLY REMAINED. IT WAS EXPLAINED THAT THE OPEN TECHNIQUE (OP) WILL BE PERFORMED IN FEBRUARY NEXT YEAR, THE ANEURYSM WILL BE TREATED WHEN THE PATIENT RECOVERS, AND THE CATHETER WILL BE REMOVED AT THE SAME TIME. IN THIS CASE, SINCE THE CATHETER WAS CAUGHT IN THE STENT STRUT AND WAS REMAINED, AND IT IS LIKELY THAT THERE ARE SAME BLOOD CLOTS IN THE SURROUNDING AREA, PERCUTANEOUS RETRIEVE WILL NOT BE PERFORMED. WHEN PULLING OUT THE CATHETER, IT WAS HIGHLY LIKELY THAT IT WAS TORN OFF WHILE BEING CAUGHT ON THE STENT STRUT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FRACTURED PIECE WAS REMAINED IN THE PATIENT'S BODY (SCHEDULED TO BE RETRIEVED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347534 RADIFOCUS GLIDECATH INTRODUCER, CATHETER DQO TERUMO CORPORATION, ASHITAKA N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other