BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO-INTRODUCER KIT

    MDR report key: 14632046 · Received June 8, 2022

    Report

    Report Number
    2134812-2022-00034
    Event Type
    Injury
    Date Received
    June 8, 2022
    Date of Event
    May 16, 2022
    Report Date
    May 16, 2022
    Manufacturer
    VASCULAR SOLUTIONS, LLC
    Product Code
    DYB
    PMA / PMN Number
    K180913
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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

    ONE-UNIT OF MIK GUIDEWIRE WAS RETURNED FOR EVALUATION. BLOOD PARTICULATES WERE NOTED ON THE UNIT. THE WIRE WAS STUCK WITHIN THE NEEDLE. THE COIL WAS UNRAVELED. THE UNIT WAS REMOVED FROM THE NEEDLE. THERE WAS NO LOT NUMBER PROVIDED FOR THIS COMPLAINT. BASED ON THE SALES DISTRIBUTION TO THE ACCOUNT, DEVICE HISTORY RECORD REVIEW WAS REQUESTED FOR POSSIBLE LOTS. NO NONCONFORMANCES WERE NOTED. CASE DETAILS WERE REVIEWED. A 7267X UNIT WAS USED FOR IJ ACCESS. THE WIRE GOT CURLED AND GOT SHEARED WHEN PULLED OUT OF THE NEEDLE. ONE UNIT OF MIK INTRODUCER GUIDEWIRE WAS RETURNED FOR EVALUATION. THE GUIDEWIRE WAS LOCKED WITHIN THE NEEDLE. THE WIRE WAS DETACHED FROM THE NEEDLE. COIL WAS OBSERVED TO BE UNRAVELED FROM THE CORE WIRE. PER IFU THE FOLLOWING WAS NOTED: 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 FROM THE ACCOUNT. A RESPONSE WAS RECEIVED. NO PART OF THE GUIDEWIRE WAS LEFT BEHIND. LOT NUMBER IS UNAVAILABLE. NO RESPONSE WAS RECEIVED ON QUESTIONS PERTAINING TO PROCEDURAL USE AND ANATOMICAL FACTORS. NO FLUOROSCOPIC IMAGES OR VIDEOS OF THE ISSUE WERE SHARED. IT IS LIKELY THAT THE OPERATOR WITHDREW THE WIRE THROUGH THE NEEDLE LEADING TO THE INTERACTION BETWEEN THE BEVEL AND THE WIRE SHAFT CAUSING IT TO UNRAVEL. A MANUFACTURING RECORD REVIEW WAS COMPLETED BY HERAEUS ON POTENTIAL LOTS POSSIBLY SHIPPED TO THE ACCOUNT. NO RELATED NON-CONFORMANCES WERE FOUND. BASED ON THE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE ISSUE IS OPERATIONAL CONTEXT AND/OR UNINTENDED USE ERROR.

    Description of Event or Problem · 0

    AS REPORTED: THE PHYSICIAN USED A MICRO PUNCTURE KIT (MIK) FOR INTERNAL JUGULAR (IJ) ACCESS, THE WIRE GOT CURLED UP, SO SHE PULLED IT OUT AND IT SHEARED COMING BACK OUT OF THE NEEDLE. I WAS NOT PRESENT DURING THIS INCIDENT. THE RADIOLOGY TECHNICIAN WAS THERE AND EXPLAINED WHAT HAPPENED AND SAVED THE MIK TO RETURN FOR INVESTIGATION. ADDITIONAL INFORMATION RECEIVED ON 23MAY2022: NO PART OF THE GUIDEWIRE THAT WAS SHEARED WAS LEFT BEHIND IN THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18270 MICRO-INTRODUCER KIT CATHETER DYB VASCULAR SOLUTIONS, LLC 7267X

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention