BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND GUIDEWIRE

    MDR report key: 1676901 · Received May 7, 2010

    Report

    Report Number
    2939204-2010-00657
    Event Type
    Malfunction
    Date Received
    May 7, 2010
    Date of Event
    March 11, 2010
    Report Date
    April 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    DQX
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA# OR 510K#: K934122; K931584; K944677; K971254; K022357 AND K931584.PENDING FULL ANALYSIS OF THE RETURNED DEVICE.

    Additional Manufacturer Narrative · 1

    PMA# OR 510K#: K934122; K931584; K944677; K971254; K022357 AND K931584. THE GUIDEWIRE WAS RECEIVED IN TWO PIECES: THE DISTAL SECTION MEASURED 153CM AND THE PROXIMAL SECTION MEASURED 49.5CM. VISUAL INSPECTION OF THE DEVICE FOUND SEVERAL KINKS ON THE PROXIMAL SECTION. A KINK WAS FOUND AT 81CM FROM THE FRACTURE ON THE DISTAL SECTION. BOTH PIECES OF THE GUIDEWIRE WERE FURTHER ANALYZED USING SCANNING ELECTRON MICROSCOPY (SEM). THIS REVEALED THAT THE OUTER HYPOTUBE FRACTURE SITE EXHIBITED FATIGUE STRIATIONS ALONG WITH ELONGATED DIMPLE RUPTURES IN TEAR INDICATIVE OF A BENDING ACTION. COMPRESSION AND TENSION ZONES WERE OBSERVED. NO MATERIAL ANOMALIES WERE DETECTED. THE GUIDEWIRE SEPARATION OCCURRED AS A RESULT OF FATIGUE IN A BENDING OVERLOAD DIRECTION. BASED ON THE INVESTIGATION RESULTS AND THE INFORMATION PROVIDED, THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING. THE SEPARATION OF THE GUIDEWIRE WAS LIKELY CAUSED BY EXCESSIVE FORCE APPLIED TO THE DEVICE TO OVERCOME RESISTANCE DURING ADVANCEMENT IN HIGH TORTUOUS ANATOMY. THIS TENSILE FORCE CAN CAUSE MULTIPLE KINKS/BENDS, WHICH LED TO THE FRACTURE OF THE GUIDEWIRE. AS TORTUOUS ANATOMY AND FRICTION ARE CONSIDERED TO BE PROCEDURAL FACTORS, THEREFORE, A ROOT CAUSE OF OPERATIONAL CONTEXT HAS BEEN ASSIGNED TO THE EVENT.

    Description of Event or Problem · 1

    INITIAL VISUAL INSPECTION OF THE RETURNED DEVICE NOTED THAT IT HAD FRACTURED. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    INITIAL VISUAL INSPECTION OF THE RETURNED DEVICE NOTED THAT IT HAD FRACTURED. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MIAMI UNK532

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR WINGSPAN STENT SYSTEM (BOSTON SCIENTIFIC)