BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES

    MDR report key: 2013326 · Received March 10, 2011

    Report

    Report Number
    2939204-2011-00112
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SALT LAKE CITY
    Product Code
    DQX
    PMA / PMN Number
    K032146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED AND FOUND THE DEVICE MET ALL REQUIRED SPECIFICATIONS. THE GUIDEWIRE AND A NON-BOSTON SCIENTIFIC MICROCATHETER WERE RETURNED FOR ANALYSIS. THE GUIDEWIRE WAS KINKED AT 38.5CM FROM ITS PROXIMAL END. THE DISTAL SECTION OF THE GUIDEWIRE WAS EXAMINED UNDER MAGNIFICATION AND THE NITINOL TUBING APPEARED TO BE FIRST STRETCHED, AND THEN SEPARATED APPROXIMATELY 2.0CM FROM ITS DISTAL END. IN ADDITION, THE GUIDEWIRE'S PLATINUM COIL WAS ALSO NOTED TO BE STRETCHED AND SEPARATED. FROM THE SEVERITY OF THE STRETCHING NOTED ON THE NITINOL TUBING AND PLATINUM COIL, IT APPEARED THAT THE GUIDEWIRE HAD UNDERGONE EXCESSIVE FORCE DURING THE SHAPING OF THE GUIDEWIRE. NO OTHER ANOMALIES WERE OBSERVED. PER THE INFORMATION PROVIDED, CONTINUOUS FLUSH WAS NOT MAINTAINED. THE DIRECTIONS FOR USE FOR THIS PRODUCT FAMILY INCLUDE SPECIFIC INSTRUCTIONS ON MAINTAINING CONTINUOUS FLUSH, THEREFORE, THE CAUSE OF THE REPORTED BROKEN DISTAL END IS CONSIDERED TO BE USE RELATED. CONTINUOUS FLUSH WAS NOT MAINTAINED CAUSING FRICTION TO BUILD, LEADING TO STRETCHING AND THE SUBSEQUENT BREAKAGE OF THE GUIDEWIRE. A PROBABLE ROOT CAUSE OF USER/USE ERROR HAS BEEN ASSIGNED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED FROM THE USER FACILITY. FROM THE RESPONSES RECEIVED IT WAS DETERMINED THAT NO ISSUES WERE NOTED DURING PREPARATION OF THE DEVICE AND THAT THE TIP OF THE GUIDEWIRE WAS SHAPED WITH "DRAWING UP NEEDLE".

    Description of Event or Problem · 1

    THE DISTAL PORTION OF THE GUIDEWIRE BROKE DURING USE. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE DISTAL PORTION OF THE GUIDEWIRE BROKE DURING USE. THE PROCEDURE WAS COMPLETED WITH THE USE FO ANOTHER DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - SALT LAKE CITY M00313010 B21199

    Patients

    Seq Age Sex Outcome Treatment
    1 ECHELON 10 STRAIGHT MICROCATHETER (EV3)