BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARIVEIN IC INFUSION CATHETER

    MDR report key: 7318364 · Received March 6, 2018

    Report

    Report Number
    3005831739-2018-00012
    Event Type
    Malfunction
    Date Received
    March 6, 2018
    Date of Event
    October 17, 2017
    Report Date
    March 6, 2018
    Manufacturer
    VASCULAR INSIGHTS LLC
    Product Code
    KRA
    UDI-DI
    10854339004027
    PMA / PMN Number
    K071468
    Removal / Correction Number
    3005831739-11-09-17-123R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FAILURE MODE, DIFFICULTY OF INSERTION, WAS FULLY INVESTIGATED AND WAS ISOLATED TO ONE LOT OF PRODUCT AS IDENTIFIED IN THIS REPORT. ROOT CAUSE ANALYSIS WAS PERFORMED AND CORRECTIVE ACTIONS IDENTIFIED AND IMPLEMENTED. SINCE THE IMPLEMENTATION OF CORRECTIVE ACTION THERE HAVE BEEN NO FURTHER EVENTS OF THIS NATURE REPORTED.

    Description of Event or Problem · 1

    THE DOCTOR PREPARED THE PATIENT FOR THE PROCEDURE BY INSERTING THE INTRODUCER SHEATH. PHYSICIAN REMOVED THE CLARIVEIN CATHETER PART NUMBER (B)(4) FROM THE PACKAGING AND PROCEEDED TO INSERT THE CATHETER ASSEMBLY INTO THE INTRODUCER SHEATH. THE PHYSICIAN ENCOUNTERED DIFFICULTY ADVANCING THE CATHETER INTO THE INTRODUCER SHEATH. PHYSICIAN DISCARDED THE DEVICE AND OPENED A NEW ONE TO COMPLETE THE PROCEDURE WITH NO OTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159419 CLARIVEIN IC INFUSION CATHETER CLARIVEIN IC INFUSION CATHETER KRA VASCULAR INSIGHTS LLC 65-018-E4S BM651403017I 10854339004027

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR