BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO-INTRODUCER KIT

    MDR report key: 11374165 · Received February 24, 2021

    Report

    Report Number
    1649395-2021-00001
    Event Type
    Malfunction
    Date Received
    February 24, 2021
    Date of Event
    December 2, 2020
    Report Date
    February 24, 2021
    Manufacturer
    GALT MEDICAL CORPORATION
    Product Code
    DQX
    UDI-DI
    04046964327483
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT AVAILABLE FOR EVALUATION AND IT WAS DISCARDED BY END USER. INVESTIGATION CONDUCTED BASED ON DHRS REVIEW; DOCUMENTATION SHOWS THERE WAS NO ABNORMALITY OR NONCONFORMANCE RECORDED DURING MANUFACTURING PROCESS. BASED ON COMPLAINT OR EVENT DESCRIPTION RECEIVED FROM END USER, THE WIRE MET A RESISTANCE THEN IT WAS REMOVED WHILE THE NEEDLE WAS STILL IN THE POSITION AND THIS IS WHERE THE WIRE WILL BE SHEARED OFF WHEN RETRIEVING THE WIRE OVER THE NEEDLE. ALSO, THERE WERE MULTIPLE INSERTION ATTEMPTS WITH THE WIRE WHILE THE NEEDLE WAS IN POSITION. IFU INDICATE; DO NOT WITHDRAW THE GUIDEWIRE BACK INTO THE CANNULA AS THIS MAY RESULT IN SEPARATION OF THE GUIDEWIRE. THE INTRODUCER CANNULA SHOULD BE REMOVED FIRST. IF THE GUIDEWIRE MUST BE WITHDRAWN WHILE NEEDLE IS INSERTED, REMOVE BOTH THE NEEDLE AND THE WIRE AS A UNIT TO PREVENT THE NEEDLE FROM DAMAGING OR SHEARING OF THE GUIDEWIRE. THE CANNULA MUST BE REMOVED FIRST. POSSIBLE ROOT CAUSE FOR THIS OCCURRENCE; END USER DID NOT FOLLOW IFU.

    Description of Event or Problem · 1

    AS RECEIVED BY MANUFACTURER FROM END USER/SALES REP. THE GUIDEWIRE BROKE IN THE PATIENT AS IT WAS BEING USED, AND THE PIECE COULD NOT BE RETRIEVED. USING THE 4FR MICRO[?]PUNCTURE KIT, FLEXIBLE TIP WIRE WAS PASSED THROUGH THE WIRE AND MET RESISTANCE. THE WIRE WAS REMOVED AND THE ACCESS NEEDLE ANGLE WAS CHANGED SLIGHTLY WITHOUT REMOVING VEIN ACCESS AND MAINTAINING ASPIRATION OF VENOUS BLOOD. THE FLEXIBLE TIP WIRE WAS PASSED AGAIN AND MET RESISTANCE. IT WAS EASILY REMOVED, BUT ON EXAMINATION AND FLUOROSCOPY IT WAS NOTED THAT THE TIP HAD SHEARED OFF. MULTIPLE FLUOROSCOPIC IMAGES DEMONSTRATED A FIXED WIRE TIP IN THE LOCATION MEDIAL TO THE SUBCLAVIAN OR INTERNAL JUGULAR VEINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273715 MICRO-INTRODUCER KIT 4F MICRO-INTRODUCER KIT, PACKAGED STERILE FOR B BRAUN 610373 DQX GALT MEDICAL CORPORATION KIT-018-61 P20071029 04046964327483

    Patients

    Seq Age Sex Outcome Treatment
    1 Other