BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COURIER - MICROCATHETER

    MDR report key: 2852906 · Received November 30, 2012

    Report

    Report Number
    2954740-2012-00799
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    DQO
    PMA / PMN Number
    K092702
    Removal / Correction Number
    1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    NOTE: THE CATALOG NUMBER REPORTED ON THE INITIAL SUBMISSION INDICATED AS MST17000000 WHICH CORRESPONDS TO COURIER MICROCATHETER INSTEAD OF MST2700000 PROWLER 27 MICROCATHETER. THIS REPORT IS BEING SUBMITTED TO CORRECT THE CATALOG NUMBER FROM MST17000000 TO MST27000000. DURING AN ATTEMPT TO INTRODUCE A PIPELINE STENT INTO THE PROWLER 27 HUB, THE STENT SHEATH BEGAN TO BACK OUT OF THE HUB. UPON INSPECTION APPROXIMATELY 90 OF THE STENT HAD PASSED INTO THE CATHETER, WITH 10% VISIBLE IN THE CLEAR PART OF THE HUB. THE PROWLER 27 WAS REMOVED AS A UNIT WITH THE PIPELINE STENT SYSTEM. A MARKSMAN MICROCATHETER WAS THEN UTILIZED USING THE SAME RHV WITH SUCCESSFUL DEPLOYMENT OF A NEW STENT. THE PROWLER 27 WAS RECEIVED FOR ANALYSIS. THE LUMEN ID OF THE RETURNED UNIT MET SPECIFICATIONS AND THE HUB ID WAS VERIFIED BY USING THE APPROPRIATE PIN GAUGE TO BE WITHIN SPECIFICATION. NO FLASHES AND NO SHARP EDGES WERE OBSERVED ON/IN THE HUB. A NITINOL MANDREL, OD 0.007 -WAS INSERTED INTO THE HUB FROM DIFFERENT ANGLES, THE TRANSITION WAS SMOOTH AND WITHOUT ANY GAPS. THERE WAS NO OBSTRUCTION IN THE LUMEN OF THE RETURNED DEVICE AND NO INNER LUMEN RESISTANCE OR OBSTRUCTION DURING FUNCTIONAL TESTING. THE SHAFT WAS NOT OCCLUDED BY ANY FOREIGN BODY OR WRINKLED PTFE. THERE WERE NO ABNORMALITIES WITH FUNCTIONAL TESTING OF THE RETURNED PROWLER 27 SHAFT INNER LUMEN OR HUB AND THE INNER DIAMETERS MET SPECIFICATION WITHOUT OBSTRUCTIONS. ALTHOUGH A DEFINITIVE CONCLUSION CANNOT BE MADE IT APPEARS THAT PROCEDURAL FACTORS RELATED TO THE INTRODUCTION OF THE PIPELINE INTO THE PROWLER 27 CONTRIBUTED TO THE EVENT. WITH ANALYSIS OF THE RETURNED PROWLER 27 THERE IS NO INDICATION OF ANY DEVICE ANOMALIES CONTRIBUTING TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    AS REPORTED, PIPELINE SHEATH WAS INTRODUCED INTO THE PROWLER 27 HUB. UPON ATTEMPTING TO PASS THE STENT, THE STENT SHEATH BEGAN TO BACK OUT OF THE HUB. UPON INSPECTION, APPROXIMATELY 90% OF THE STENT PASSED INTO THE CATHETER WITH 10% VISIBLE IN THE CLEAR HUB. THE PROWLER 27 WAS REMOVED WITH THE STENT SYSTEM TRAPPED AND REPLACED WITH A MARKSMAN UTILIZING THE SAME RHV AS BEFORE. SUCCESSFUL DEPLOYMENT OCCURRED WITH A NEW STENT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE STENT USED WAS PIPELINE. THE GUIDEWIRE USED WAS UNKNOWN. THE STENT AND THE MICROCATHETER WAS WITHDRAWN AS A UNIT WHEREBY LOSING IT'S TARGET POSITION IN THE INTRACRANIAL VASCULATURE. AN ADEQUATE CONTINUOUS FLUSH MAINTAINED THROUGH THE MICROCATHETER. NO DAMAGE TO THE MICROCATHETER PRIOR TO USE. IT VERIFIED THAT THE INTRODUCER FULLY SEATED AND SECURED IN THE HUB. UNSURE IF THE DEVICE MOVED OUT FORWARD OUT OF THE INTRODUCER DURING INSERTION THRU THE Y-CONNECTOR OR IN THE HUB. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COURIER - MICROCATHETER CES MICROCATHETERS DQO MICRUS ENDOVASCULAR, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN GUIDEWIRE