BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO-INTRODUCER KIT

    MDR report key: 15263248 · Received August 20, 2022

    Report

    Report Number
    2134812-2022-00050
    Event Type
    Malfunction
    Date Received
    August 20, 2022
    Date of Event
    July 27, 2022
    Report Date
    August 3, 2022
    Manufacturer
    VASCULAR SOLUTIONS, LLC
    Product Code
    DYB
    UDI-DI
    10841156107109
    PMA / PMN Number
    K180913
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN OPENED TO REVIEW DEVICE HISTORY RECORD AND RISK DOCUMENTATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THERE WAS NO PRODUCT RETURNED FOR THIS COMPLAINT. NO RETURNED PRODUCT EVALUATION COULD BE COMPLETED. INTRODUCER WIRE PACKED IN THE MIK KIT IS A SUPPLIED COMPONENT BY A THIRD-PARTY SUPPLIER. A DEVICE HISTORY RECORD REVIEW WAS REQUESTED FOR THE WIRE LOTS PACKED IN THE MIK LOT. NO ISSUES OR NON-CONFORMANCES NOTED BY THE THIRD-PARTY SUPPLIER. ALL PROCESS STEPS WERE PERFORMED CORRECTLY. CASE DETAILS WERE REVIEWED. IT IS UNKNOWN WHAT DEGREE OF DAMAGES HAVE OCCURRED ON THE SHAFT OF THE WIRE. PER IFU THE FOLLOWING WARNING AND PRECAUTION WAS IDENTIFIED: NEVER ADVANCE OR WITHDRAW AN INTRAVASCULAR DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THE RESISTANCE IS DETERMINED BY FLUOROSCOPY. MOVEMENT OF THE GUIDEWIRE AGAINST RESISTANCE MAY RESULT IN SEPARATION OF THE GUIDEWIRE TIP, DAMAGE TO THE GUIDEWIRE, OR VESSEL PERFORATION. DO NOT WITHDRAW THE GUIDEWIRE THROUGH THE NEEDLE. IF NECESSARY, REMOVE BOTH THE NEEDLE AND GUIDEWIRE AS A UNIT TO PREVENT THE NEEDLE FROM DAMAGING OR SHEARING THE GUIDEWIRE. ADDITIONAL INFORMATION WAS REQUESTED. PATIENT CONDITION IS FINE. NO PARTS OF THE WIRE WERE LEFT IN THE PATIENT. NO RESPONSE WAS RECEIVED ON OTHER QUESTIONS RELATED TO THE PROCEDURE OR USE OF THE WIRE. NO PICTURES OF THE ISSUE WERE PROVIDED. BASED ON THE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE ISSUE IS UNDETERMINABLE.

    Description of Event or Problem · 0

    DISTAL COIL OF MIK WIRE UNRAVELED. ADDITIONAL INFORMATION ON 17AUG2022: THE ACCOUNT REPORTED NOTHING WAS LEFT IN THE PATIENT, AND THE PATIENT IS FINE. AFTER MULTIPLE GOOD FAITH ATTEMPTS, THE ACCOUNT WOULD NOT RELEASE ANY ADDITIONAL INFORMATION OR RESPOND TO THE REQUESTED QUESTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252755 MICRO-INTRODUCER KIT CATHETER DYB VASCULAR SOLUTIONS, LLC 7264V 73C2200198 10841156107109

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown