BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KITTYCAT2

    MDR report key: 3070595 · Received April 17, 2013

    Report

    Report Number
    3007498664-2013-00002
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 15, 2013
    Report Date
    April 17, 2013
    Manufacturer
    AVINGER
    Product Code
    DQY
    PMA / PMN Number
    K112579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE CASE INFO, INCLUDING THE DEVICE USE FEEDBACK OBTAINED FROM THE EVENT REPORTER, WAS USED TO EVALUATE THE DEVICE PERFORMANCE. RESULTS: THE IFU CONTAINS WARNINGS AND PRECAUTIONS THAT "IF RESISTANCE IS MET DURING MANIPULATION, DETERMINE THE CAUSE OF THE RESISTANCE BEFORE PROCEEDING" AND TORQUING OR PULLING THE CATHETER EXCESSIVELY MAY CAUSE DAMAGE TO THE PRODUCT. EXCESSIVE BENDING OR KINKING OF THE CATHETER MAY AFFECT PERFORMANCE." DEVICE EVALUATION SUMMARY - RETURNED DEVICE EVALUATION CONFIRMED THE SEPARATION OF THE TIP AS A RESULT OF MANIPULATION IN ATTEMPT TO FREE UP THE DEVICE WHEN IT GOT STUCK IN THE LESION. THE CATHETER TIP SEPARATED FROM THE OUTER SHAFT BUT REMAINED ATTACHED TO THE INNER SHAFT. CHANGES TO PERSONNEL REVIEWING PREDICATE EVENTS FOR REPORTING INCLUSION RESULTED IN THE DELAYED MDR SUBMISSION FOR THIS REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PT PRESENTED FOR REVASCULARIZATION OF A MILDLY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. WITH THE KITTYCAT2 (W550), THE PHYSICIAN HAD ADVANCED HALF WAY THROUGH THE LESION BEFORE THE DEVICE TIP BECAME STUCK IN THE LESION. WHEN THE PHYSICIAN PULLED BACK ON THE DEVICE IN AN ATTEMPT TO FREE UP THE CATHETER, THE TIP SEPARATED FROM THE CATHETER'S OUTER SHEATHING BUT REMAINED ATTACHED TO THE INNER SHAFT. THE ENTIRE CATHETER INCLUDING THE SEPARATED TIP WAS REMOVED AS ONE UNIT. THE PHYSICIAN USED A SECOND KITTYCAT2 AND CROSSED THE LESION SUCCESSFULLY. THERE WAS NO PT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165642 KITTYCAT2 KITTYCAT2 DQY AVINGER W550 130104005

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR