BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIFLEX? RX DELIVERY SYSTEM

    MDR report key: 3203600 · Received July 3, 2013

    Report

    Report Number
    3005099803-2013-06080
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    April 17, 2013
    Report Date
    June 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND OUT THAT THE PULL WIRE WAS BENT AND KINKED AT SEVERAL LOCATIONS. PUSH CATHETER HAD A TEAR NEAR THE HANDLE. A KINK WAS FOUND ON THE PUSH CATHETER ADJACENT TO THE PROXIMAL SIDE OF THE RO MARKER. A FUNCTIONAL EVALUATION FOUND THAT GUIDEWIRE ADVANCED THROUGH THE DEVICE WITH OUT ISSUE. THE NOTED DAMAGE IS LIKELY DUE TO PROCEDURAL OR ANATOMICAL FACTORS ENCOUNTERED DURING THE PROCEDURE SUCH TORTUOUS ANATOMY OR MANEUVERING OF THE DEVICE, THEREFORE THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX DELIVERY SYSTEM WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE STENT SYSTEM DID NOT SLIDE PROPERLY ON THE GUIDEWIRE AND THE STENT GOT KINKED. THE PROCEDURE WAS NOT COMPLETED AND WAS POSTPONED AS THEY WERE NO OTHER DEVICES AVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; PUSH CATHETER BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304269 NAVIFLEX? RX DELIVERY SYSTEM BILIARY CATHETERS AND ACCESSORIES FGE BOSTON SCIENTIFIC - SPENCER M00533560 14841168

    Patients

    Seq Age Sex Outcome Treatment
    1