BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING

    MDR report key: 1862302 · Received October 8, 2010

    Report

    Report Number
    2134265-2010-04449
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    July 6, 2010
    Report Date
    September 20, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    DQX
    PMA / PMN Number
    K945379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. EXAMINATION REVEALED SEVERELY ELONGATED COILS AND A FRACTURED COREWIRE LOCATED 1CM FROM THE DISTAL TIP. THE OUTSIDE DIAMETER OF THE WIRE WAS MEASURED AND FOUND TO MEET SPECIFICATION. SCANNING ELECTRON MICROSCOPY OF THE FRACTURED CORE WIRE DETERMINED THAT THE FRACTURE OCCURRED WITHIN THE FLAT RIBBON PORTION OF THE WIRE ADJACENT TO THE TRANSITION AREA. A NOTICEABLE TWIST IN THE WIRE WAS NOTED. THE FRACTURE SURFACE EXHIBITED ELONGATED DIMPLE RUPTURES IN A TORSIONAL DIRECTION. NO MATERIAL ANOMALIES WERE NOTED. THE CORE WIRE FRACTURE WAS DUE TO A TORSIONAL OVERLOAD. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING AN ANTEGRADE STICK TREATMENT PROCEDURE, THE GUIDE WIRE UNRAVELED. THE PHYSICIAN WAS TREATING A LESION LOCATED IN A VESSEL OF THE RIGHT LEG, BELOW THE KNEE, WITH A PLATINUM PLUS .014 GUIDE WIRE. THE ANATOMY WAS TORTUOUS AND A HIGH BURDEN OF PLAQUE WAS PRESENT. THE GUIDE WIRE WAS USED IN THE RIGHT LEG AND THEN SET ASIDE ON THE STERILE TABLE. THERE WASN'T ANYTHING UNUSUAL NOTICED WITH THE DEVICE DURING USE. AFTER ABOUT 20 MINUTES, THEY WANTED TO USE THE WIRE AGAIN IN THE LEFT LEG. THIS IS WHEN THEY NOTICED THE DISTAL PORTION OF THE GUIDE WIRE HAD UNRAVELED. THERE DIDN'T SEEM TO BE ANYTHING MISSING FROM THE DEVICE OR ANY WIRE BREAKS. THE DEVICE WAS NOT USED AGAIN. THE VESSEL IN THE LEFT LEG WAS TREATED WITH ANOTHER PLATINUM PLUS GUIDE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A FRACTURED CORE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MIAMI M001467120 0013237926

    Patients

    Seq Age Sex Outcome Treatment
    1