BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO-INTRODUCER KIT

    MDR report key: 7441273 · Received April 18, 2018

    Report

    Report Number
    2134812-2018-00025
    Event Type
    Malfunction
    Date Received
    April 18, 2018
    Date of Event
    August 1, 2017
    Report Date
    August 1, 2017
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Product Code
    DYB
    UDI-DI
    M2067266V1
    PMA / PMN Number
    K101604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING BASED ON THE VISUAL INVESTIGATION AND CONDITION OF THE RETURNED SAMPLE. A MANUFACTURING RECORD REVIEW WAS COMPLETED AND ZERO NONCONFORMANCES WERE FOUND. THE RETURNED PRODUCT EVALUATION CONFIRMED THE PUNCTURE/HOLE IN THE SHEATH. THE SHEATH WAS KINKED AT THE SECTION WHERE THE HOLE WAS PRESENT. BASED ON THE EVENT DETAILS THE MOST LIKELY ROOT CAUSE FOR THE FAILURE IS THE MANDREL PUNCTURED THE SHEATH AS THE DOCTOR WAS TRYING TO ADVANCE THE SHEATH.

    Description of Event or Problem · 1

    DR. WAS USING MIK FOR ACCESS IN A VARILASE CASE. WHEN HE TRIED TO ADVANCE THE 035"" J-TIP WIRE THROUGH THE MIK SHEATH, HE FELT RESISTANCE. DR. THAN REMOVED THE J-TIP WIRE, AND USED THE MIK MANDREL TO ADVANCE AND REMOVED THE MIK SHEATH. THE TIP OF THE SHEATH SHOWED A PUNCTURE AT THE DISTAL TIP. MIK SHEATH REMOVED AND PLACED IN BIOHAZARD BAG WITH PACKAGING. NO PATIENT IMPACT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284836 MICRO-INTRODUCER KIT INTRODUCER CATHETER DYB VASCULAR SOLUTIONS, INC. 7266V 594179 M2067266V1

    Patients

    Seq Age Sex Outcome Treatment
    1