BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND¿ EX

    MDR report key: 2171750 · Received July 22, 2011

    Report

    Report Number
    2939204-2011-00376
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K934122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO ISSUES WERE FOUND. THE DHR REVIEW SHOWED DEVICE MET ALL REQUIRED SPECIFICATIONS UPON ITS RELEASE. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE GUIDEWIRE WAS NOT FRACTURED AS ORIGINALLY REPORTED BUT RATHER THE TIP HAD BENDS AT 12.5 CM, 13.5 CM, 14.5 CM AND 15.5 CM FROM THE DISTAL END. AS THE DEVICE DOES NOT PRESENT ANY TYPE OF FRACTURE ALONG THE BODY AND NO ADDITIONAL INFORMATION WAS PROVIDED BY USER FACILITY, IT IS POSSIBLE THAT THE DEVICE MAY HAVE BEEN UNLOADED FROM THE DISTAL SECTION OF THE GUIDEWIRE. THE PHYSICIAN WOULD MOST LIKELY HAVE HAD TO APPLY ADDITIONAL FORCE TO OVERCOME THE RESISTANCE RESULTING IN THE BENDS NOTED AT THE TIP OF THE DEVICE. THEREFORE THE ROOT CAUSE WAS MOST LIKELY THE RESULT OF HANDLING DAMAGE. THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENTS OF A REPORTABLE EVENT FOR THE DEVICE IN QUESTION IN THAT THE DEVICE WAS NOT FOUND TO BE BROKEN AS ORIGINALLY REPORTED BUT KINKED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED FROM THE USER FACILITY. FROM THE RESPONSES RECEIVED IT WAS DETERMINED THAT THERE WAS NO DAMAGE NOTED TO THE PACKAGING, THE DISPENSER HOOP HAD BEEN FLUSHED WITH SALINE AND THAT TENSILE FORCE WAS APPLIED IN ORDER TO REMOVE THE DEVICE FROM THE DISPENSER HOOP THEREBY CAUSING THE DISTAL SECTION TO BREAK.

    Description of Event or Problem · 1

    THE GUIDEWIRE BROKE AFTER MEETING RESISTANCE AS IT WAS REMOVED FROM THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE GUIDEWIRE BROKE AFTER MEETING RESISTANCE AS IT WAS REMOVED FROM THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND¿ EX WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA M001468050 13458921

    Patients

    Seq Age Sex Outcome Treatment
    1