BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA 3MAX REPERFUSION CATHETER

    MDR report key: 3233136 · Received July 18, 2013

    Report

    Report Number
    3005168196-2013-00283
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K113163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE DISTAL PORTION OF THE CATHETER IS SEVERELY DAMAGED. THE DISTAL TIP IS PINCHED, STRETCHED, AND BROKEN. THE BREAK SITE SHOWS EVIDENCE OF STRETCHING AND EXTREME MATERIAL DEFORMATION. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED AND CONFIRMED. THE COMPLAINT STATES THAT THE PATIENT HAD A VERY TORTUOUS ANATOMY. IT WAS ALSO INDICATES THAT THE PHYSICIAN HAD TROUBLE KEEPING THE GUIDE CATHETER IN THE VESSEL. IT IS LIKELY THAT THE CATHETER BECAME TRAPPED EITHER IN THE PATIENT'S TORTUOUS ANATOMY OR INSIDE THE GUIDE CATHETER AND WHEN THE PHYSICIAN ATTEMPTED TO MANIPULATE THE CATHETER AGAINST THE RESISTANCE, THE TENSILE STRENGTH OF THE MATERIAL WAS EXCEEDED, CAUSING THE CATHETER TO BREAK. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    PATIENT HAD A VERY TORTUOUS ANATOMY WITH THREE 90 DEGREE LOOPS TO GET TO THE M1. THE PHYSICIAN HAD TROUBLE KEEPING THE GUIDE CATHETER IN THE VESSEL AS IT KEPT PROLAPSING, WHICH MADE THE CASE VERY DIFFICULT. FIRST AN SL10 MICROWIRE TIP BROKE IN THE CATHETER AND ABOUT AN HOUR LATER THE TIP OF THE 3MAX REPERFUSION CATHETER BROKE. THE PHYSICIAN WAS ABLE TO WITHDRAW THE DAMAGED CATHETERS FROM THE PATIENT WITH NO ADVERSE EVENTS OCCURRING. THE PROCEDURE WAS FINISHED AND WRITTEN UP AS UNREMARKABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333554 PENUMBRA 3MAX REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F32722

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR