BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK RADIFOCUS GLIDEWIRE

    MDR report key: 7534017 · Received May 22, 2018

    Report

    Report Number
    9681834-2018-00085
    Event Type
    Injury
    Date Received
    May 22, 2018
    Date of Event
    March 7, 2018
    Report Date
    May 22, 2018
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI - UNKNOWN DUE TO UNKNOWN PRODUCT CODE/LOT NUMBER. POTENTIAL UDI #: (B)(4) D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. A REVIEW OF THE DEVICE HISTORY RECORD OF THE POTENTIAL PRODUCT CODE/LOT#: GR3508 (RF*GA35183A)/171113 COMBINATION WAS CONDUCTED WITH NO FINDINGS. WITH NO DEVICE RETURN 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. EXEMPTION NUMBER E2015022. - ATTACHMENT: [UF MEDWATCH (B)(4).PDF]

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE A CORRECTION. IT WAS INADVERTENTLY REPORTED ADVERSE EVENT OR PRODUCT PROBLEM, OUTCOMES ATTRIBUTED TO ADVERSE EVENT AND TYPE OF REPORTABLE EVENT. THE EVENT WAS AN ADVERSE AND OTHER SERIOUS IN THE INITIAL REPORT. HOWEVER, THE EVENT REPORTED WAS DEEMED A MALFUNCTION AND THEREFORE THE SECTIONS HAVE BEEN CORRECTED.

    Description of Event or Problem · 0

    TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH (B)(4), WHICH REPORTED: WHEN ACCESSING THE CEPHALIC VEIN FOR A PACEMAKER INSERTION, A GLIDEWIRE WAS INSERTED INTO THE VEIN AND WIRE INTRODUCER WAS ALSO ADVANCED INTO THE VEIN. THE GLIDEWIRE WAS REMOVED FROM THE VEIN BUT NOT THE INTRODUCER. THEY WERE UNABLE TO VISUALIZE THE INTRODUCER UNDER FLUOROSCOPY.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 2 TO PROVIDE ADDITIONAL INFORMATION. PATIENT WEIGHT: (B)(6) KG.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON MAY 22, 2018. THE USER FACILITY WAS UNABLE TO DETERMINE WHICH COMPONENT IT WAS, THAT WAS DESCRIBED AS THE INTRODUCER. ACCESS WAS ACHIEVED THROUGH CUT DOWN, AND THE COMPONENT WAS LEFT IN THE PATIENT. THE PATIENT WAS IN STABLE CONDITION BOTH PRIOR AND AFTER THE PACEMAKER INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376600 UNK RADIFOCUS GLIDEWIRE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA N/A 171113

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Other