BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)

    MDR report key: 7488251 · Received May 4, 2018

    Report

    Report Number
    1118880-2018-00036
    Event Type
    Injury
    Date Received
    May 4, 2018
    Date of Event
    April 13, 2018
    Report Date
    May 4, 2018
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    UDI-DI
    00389701010786
    PMA / PMN Number
    K142183
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER - REQUESTED, NOT PROVIDED. DATE OF BIRTH - REQUESTED, NOT PROVIDED. ETHNICITY - REQUESTED, NOT PROVIDED. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. THE 510(K): K152173. PATIENT WAS REPORTED TO BE (B)(6). THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. FOR A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE COMPLETED INVESTIGATION. ONE 0.021" WIRE WAS RECEIVED FOR PRODUCT ANALYSIS. AFTER DECONTAMINATION, THE GUIDEWIRE WAS SUBJECTED TO VISUAL ANALYSIS. THE DISTAL TIP OF THE GUIDEWIRE HAD UNCOILED TO THE POINT WHERE THE COIL IS FUSED WITH THE CORE OF THE GUIDE WIRE. 20.5" OF WIRE HAD UNCOILED. MICROSCOPY OF THE DISTAL TIP APPEARS BLUNT UNDER MICROSCOPY AS THOUGH IT WAS EXPOSED TO A SHARP EDGE. IFU STATES "DO NOT WITHDRAW THE GUIDE WIRE THROUGH THE CANNULA, AS SHEARING OF THE GUIDE WIRE MAY RESULT." THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. GUIDEWIRE SHEARING MAY OCCUR IF THE GUIDEWIRE IS WITHDRAWN THROUGH THE NEEDLE WHICH THE IFU WARNS AGAINST.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE PHYSICIAN ACCESSED THE RADIAL ARTERY WITH THE SUPPLIED NEEDLE, AND HE INTRODUCED THE NITINOL WIRE THROUGH THE NEEDLE AND INTO THE ARTERY. WHEN THE PHYSICIAN REMOVED THE NEEDLE, IT WAS DISCOVERED THE NITINOL WIRE HAD COME UNWOUND AND THE DISTAL TIP BROKE OFF INTO THE ARTERY. THE PHYSICIAN WAS ABLE TO RETRIEVE THE TIP OF THE WIRE FROM THE PATIENT'S ARTERY. THE PATIENT WAS REPORTED TO BE DOING FINE FOLLOWING THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 19, 2018. THE EVENT OCCURRED INTRA-OPERATIVE. THERE WAS NO BLOOD LOSS REPORTED. THEY USED A SNARE WAS USED TO RETRIEVE THE BROKEN END FROM THE PATIENT'S ARTERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. OTHER EQUIPMENT OR OTHER DEVICES USED WITH THE DEVICE WERE: J TIP WIRE, DIAGNOSTIC CATH, AND A PIG TAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330097 GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT) INTRODUCER, CATHETER DYB TERUMO MEDICAL CORPORATION N/A WA10 00389701010786

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention