BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSEND EX PLATINUM GUIDEWIRE

    MDR report key: 1972004 · Received January 27, 2011

    Report

    Report Number
    2939204-2011-00016
    Event Type
    Injury
    Date Received
    January 27, 2011
    Date of Event
    December 22, 2010
    Report Date
    January 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K971254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE DEVICE WAS FRACTURED APPROXIMATELY 201.5CM FROM THE PROXIMAL END. SCANNING ELECTRON MICROSCOPY OF THE FRACTURE SURFACE DEMONSTRATED THAT THE FRACTURE SITE EXHIBITED MATERIAL ELONGATION/REDUCTION ALONG WITH ELONGATED DIMPLE RUPTURES IN A SHEAR PLANE. NO MATERIAL ANOMALIES WERE NOTED. BASED ON THE PRODUCT ANALYSIS, THE DEVICE FRACTURED DUE TO TENSILE OVERLOAD. BASED ON THE INVESTIGATION AND THE INFORMATION PROVIDED, IT IS MOST LIKELY THAT FORCE WAS APPLIED TO THE DEVICE, AFTER IT BECAME STUCK IN THE LESION, IN AN ATTEMPT TO REMOVE THE DEVICE AND THIS RESULTED IN THE REPORTED BROKEN TIP. THEREFORE, IT WAS CONCLUDED THAT OPERATION CONTEXT WAS THE MOST LIKELY CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FROM THE USER FACILITY STATED THAT NO RESISTANCE WAS ENCOUNTERED DURING THE USE OF THE DEVICE PRIOR TO IT BECOMING STUCK IN THE THROMBUS. THE PHYSICIAN HAD BEEN ATTEMPTING TO CROSS THE DILATION WITH THE DEVICE AND MICROCATHETER SO THAT A STENT COULD BE PLACED TO TREAT THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE OFF AND WAS IN THE THROMBOSED AREA OF THE DISSECTED MIDDLE CEREBRAL ARTERY ANEURYSM. THE TIP WAS RETRIEVED USING A SNARE DEVICE AND THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH A PARTIALLY THROMBOSED FUSIFORM DILATION OF THE RIGHT MIDDLE CEREBRAL ARTERY M1 SEGMENT POSSIBLY DUE TO A DISSECTION. AS THE PHYSICIAN WAS ATTEMPTING TO CROSS THE DILATION, THE DEVICE BECAME STUCK IN THE THROMBUS. THE PHYSICIAN PULLED AND TORQUED THE DEVICE IN ATTEMPT TO FREE THE DEVICE FROM THE THROMBUS AND DURING THIS MANIPULATION THE TIP BROKE OFF. THE TIP WAS RETRIEVED USING A SNARE DEVICE AND THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE OFF AND WAS IN THE THROMBOSED AREA OF THE DISSECTED MIDDLE CEREBRAL ARTERY ANEURYSM. THE TIP WAS RETRIEVED USING A SNARE DEVICE AND THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND EX PLATINUM GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA M001468080 13781081

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention VASCO 21 MICROCATHETER (MANUFACTURER UNKNOWN)