BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO-INTRODUCER KIT

    MDR report key: 13911545 · Received March 25, 2022

    Report

    Report Number
    2134812-2022-00025
    Event Type
    Injury
    Date Received
    March 25, 2022
    Date of Event
    January 3, 2022
    Report Date
    March 7, 2022
    Manufacturer
    VASCULAR SOLUTIONS, LLC
    Product Code
    DYB
    PMA / PMN Number
    K180913
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN OPENED AND 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. THERE WAS NO LOT NUMBER PROVIDED FOR THIS COMPLAINT. THEREFORE, NO RECORD REVIEW COULD BE COMPLETED CASE DETAILS WERE REVIEWED. THE MIK WIRE WAS RETAINED WITHIN THE LEFT COMMON FEMORAL ARTERY AND APPEARED TO TANGLE WITHIN THE KNOT. NO UNIT WAS RETURNED TO VSI/TELEFLEX FOR EVALUATION. IT IS UNKNOWN WHAT DAMAGES COULD HAVE OCCURRED ON THE WIRE. IFU WAS REVIEWED. THE FOLLOWING WARNINGS AND PRECAUTIONS WERE 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. ALSO, ACCESS SITE COMPLICATIONS IS IDENTIFIED AS A POTENTIAL ADVERSE EFFECT THAT MAYBE ASSOCIATED WITH VSI MIK KIT. IT IS UNKNOWN IF THE WIRE WAS OPERATED AGAINST RESISTANCE OR WIRE WAS WITHDRAWN THROUGH THE NEEDLE. ADDITIONAL INFORMATION WAS REQUESTED FROM THE ACCOUNT. A RESPONSE WAS RECEIVED. PRODUCT WILL NOT BE RETURNED. NO LOT NUMBER WAS PROVIDED. MIK BROKE OFF AND TANGLED WITHIN THE PATIENT. PATIENT WAS SENT TO THE OR NEXT DAY TO REMOVE THE WIRE WHICH WAS SUCCESSFUL. BASED ON THE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE ISSUE IS UNDETERMINABLE.

    Description of Event or Problem · 0

    AS REPORTED: DURING PCI STENT PLACEMENT THE MICROPUNCTURE WIRE WAS RETAINED OVERLYING OR PERHAPS WITHIN THE LEFT COMMON FEMORAL ARTERY AND APPEARED TO TANGLE WITHIN THE KNOT OVERLYING THE LEFT CFA. THEN THEY WERE UNSUCCESSFUL IN REMOVING THE WIRE. PATIENT HAD AN INFECTION IN GROIN. PATIENT WENT TO OR NEXT DAY FOR REMOVAL OF THE MICRO PUNCTURE WIRE WHICH WAS SUCCESSFULLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697310 MICRO-INTRODUCER KIT CATHETER DYB VASCULAR SOLUTIONS, LLC 7256V UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention