BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO-INTRODUCER KIT

    MDR report key: 13171781 · Received January 5, 2022

    Report

    Report Number
    2134812-2022-00004
    Event Type
    Injury
    Date Received
    January 5, 2022
    Date of Event
    December 10, 2021
    Report Date
    December 10, 2021
    Manufacturer
    VASCULAR SOLUTIONS, LLC
    Product Code
    DYB
    UDI-DI
    20841156106994
    PMA / PMN Number
    K180913
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. A MANUFACTURING RECORD REVIEW WAS COMPLETED BY TECATE AND NO RELATED NONCONFORMANCES WERE FOUND. THE EVENT DESCRIPTION STATES MIK SHEATH SHEARED OFF IN THE PATIENT'S ARTERY. IT IS UNKNOWN WHAT DAMAGES OCCURRED AND HOW MUCH OF THE SHEATH WAS SHEARED OFF. ADDITIONAL INFORMATION WAS REQUESTED FROM THE ACCOUNT. A RESPONSE WAS RECEIVED. PHYSICIAN STATED THAT THE ISSUE WAS NOT RELATED TO THE MIK AS IT WAS USED IN A PATIENT WITH A VERY FIBROTIC TISSUE. PATIENT WAS SENT TO HAVE THE PIECE SURGICALLY REMOVED. SURGEON REMARKED THAT THE TISSUE WAS VERY FIBROTIC. FIBROSIS REFERS TO EXCESSIVE DEPOSITION OF COLLAGEN AND ECM PROTEINS IN THE BLOOD VESSEL (1). THIS LEADS TO SCARRING OF THE TISSUE. THIS IS LIKELY DUE TO ANATOMICAL FACTORS, THE SHEATH USED COULD HAVE BEEN MANIPULATED AGAINST RESISTANCE LEADING TO SEPARATION. PER IFU IT STATES THE FOLLOWING WARNING: 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. PHYSICIAN ALSO MENTIONS THAT IT WOULD HAVE BEEN BETTER TO NOT USE MIK AND MAY HAVE PROCEEDED WITH CUT DOWN FOR ACCESS.

    Description of Event or Problem · 0

    AS REPORTED: IN THE PROCESS OF GETTING MORE INFORMATION. CATH LAB MANAGER SENT EMAIL STATING "WE HAD A MICRO-INTRODUCER SHEAR OFF INTO A PATIENT'S ARTERY THIS WEEK. I HAVE RETAINED THE PIECE OF THE INTRODUCER THAT CAME OUT AND THE PACKAGING. WE DID SEND THE PATIENT TO HAVE THE OTHER PIECE SURGICALLY REMOVED." ADDITIONAL INFORMATION RECEIVED 27DEC2021: PHYSICIAN STATED: IT WAS NOT THE FAULT OF OUR MICRO INTRODUCER KIT AS IT WAS USED ON A PATIENT THAT KNOWING HAD VERY FIBROTIC TISSUE WHICH CAUSED THE MALFUNCTION. IN HINDSIGHT, HE STATED THAT IT WOULD HAVE BEEN BETTER TO NOT USE THE MIK AND TO HAVE A VASCULAR SURGEON CUT DOWN FOR ACCESS. WHEN THE PATIENT WAS SENT TO SURGERY TO HAVE THE REMAINING PIECE REMOVED, PHYSICIAN STATED THAT THE SURGEON WAS AMAZED AT HOW FIBROTIC THE TISSUE WAS AND WOULD NEED TO BE REMOVED BEFORE THE COULD ACCESS THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805361 MICRO-INTRODUCER KIT CATHETER DYB VASCULAR SOLUTIONS, LLC 7274V 73E2100494 20841156106994

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| R