BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI TORQUE CONNECT GUIDEWIRE

    MDR report key: 2882891 · Received December 18, 2012

    Report

    Report Number
    3006010712-2012-00011
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    October 31, 2012
    Report Date
    December 14, 2012
    Manufacturer
    BRIVANT, LTD.
    Product Code
    DQX
    PMA / PMN Number
    K112381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATCH HISTORY REVIEW CARRIED OUT DEMONSTRATES THE DEVICE WAS MANUFACTURED TO SPECIFICATION. CONSIDERING THE DAMAGE OBSERVED ON THE POLYMER JACKET AND SEVERE KINK AT THE DISTAL END, IT IS LIKELY THE GUIDEWIRE GOT CAUGHT AND THE POLYMER WAS SKIVED OFF WHEN THE USER ATTEMPTED TO RETRACT THE GUIDEWIRE. THE POLYMER JACKET SLEEVE THEN GOT PULLED FROM THE PROXIMAL END TO THE DISTAL END. THIS IS CONFIRMED BY VISUAL INSPECTION OF THE RETURNED DEVICE AND DIMENSIONAL TESTING PERFORMED. RISK ANALYSIS: A BATCH HISTORY REVIEW WAS CARRIED OUT WHICH FOCUSED PRIMARILY ON CHARACTERISTICS, WHICH MAY BE THOUGHT TO POTENTIALLY CONTRIBUTE TO THE COMPLAINT AS DESCRIBED. HOWEVER, THE REVIEW DEMONSTRATED NO INDICATION OF MANUFACTURING RELATED DEFECTS ON THE GUIDEWIRE THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE GUIDEWIRE WAS MANUFACTURED TO CORRECT SPECIFICATIONS. ANALYSIS AND CONCLUSION: MANUFACTURING CONTROLS WERE REVIEWED FOR POLYMER SIZING OPERATION (SOP665 REV26) AND POLYMER GUIDEWIRE FINAL INSPECTION (SOP654 REV17). SOP665 DESCRIBES THE POLYMER JACKET ADHESION TEST WHICH IS A 100% IN PROCESS INSPECTION. THE POLYMER JACKET DIAMETER IS ALSO A 100% IN PROCESS INSPECTION. ALL MANUFACTURING RECORDS REVIEWED SHOWED THE GUIDEWIRE WAS MANUFACTURED TO CORRECT SPECIFICATIONS. SOP654 PROVIDES ILLUSTRATIONS REGARDING THE PROXIMAL TRANSITION FROM CORE WIRE TO POLYMER. OPERATORS ARE TRAINED TO ENSURE THAT THE TRANSITION IS SMOOTH AND NOT ABRUPT IN NATURE, WHERE THERE IS A RISK OF THE WIRE GETTING SNAGGED WHEN USED. CONSIDERING THE DAMAGE OBSERVED ON THE POLYMER JACKET AND SEVERE KINK AT THE DISTAL END, IT IS LIKELY THE GUIDEWIRE GOT CAUGHT AND THE POLYMER WAS SKIVED OFF WHEN THE USER ATTEMPTED TO RETRACT THE GUIDEWIRE. THE POLYMER JACKET SLEEVE THEN GOT PULLED FROM THE PROXIMAL END TO THE DISTAL END. THIS IS CONFIRMED BY VISUAL INSPECTION OF THE RETURNED DEVICE AND DIMENSIONAL TESTING PERFORMED. THE POLYMER JACKET LENGTH WAS FOUND TO BE 52MM APPROXIMATELY. THE PORTION OF POLYMER JACKET THAT WAS FOUND TO BE PULLED OVER ITSELF IS APPROXIMATELY 34MM. THE LENGTH OF THE SEPARATED POLYMER JACKET SAMPLE MEASURE 10MM. THE SPECIFICATION FOR POLYMER JACKET LENGTH IS 80MM +/-10MM. THE TOTAL POLYMER JACKET LENGTH, AS CALCULATED FROM THE MEASUREMENTS TAKEN WOULD BE APPROXIMATELY 96MM. THIS IS NOT CONSIDERED TO BE AN OUT OF SPECIFICATION RESULT HOWEVER, AS IT MUST BE NOTED THAT THE POLYMER JACKET WAS STRETCHED OVER ITSELF WHICH WOULD CONTRIBUTE TO THE ELONGATION OF THE POLYMER. MEASUREMENTS DEMONSTRATE THAT THE SUM OF THE POLYMER JACKET LENGTH, THE OVERLAP LENGTH AND THE SEPARATED PORTION LENGTH IS GREATER THAN THE SPECIFIED OVERALL LENGTH OF THE POLYMER. POST MARKET PERFORMANCE OF THE GUIDEWIRE DEVICE DOES NOT INDICATE ANY CONCERNING TRENDS FOR THIS TY PE OF DEFECT. LAKE REGION WILL CONTINUE TO MONITOR POST MARKET EXPERIENCE FOR ANY SIMILAR TRENDS IN FUTURE. NO FURTHER ACTION IS WARRANTED AT THIS STAGE. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    THE PUNCTURE WAS DONE IN AN ANTEGRADE FASHION, BY A COOK 20G NEEDLE. A CONNECT WIRE WAS INSERTED AND THE PHYSICIAN INTENDED TO PULL BACK A LITTLE TO CORRECT THE POSITION. THE OUTER POLYURETHANE SLEEVE WAS PARTIALLY CUTTED OFF. LENGTH ABOUT 2CM. THE SURGEON WAS CALLED. THERE IS NO MORE DETAILED INFORMATION AVAILABLE AT THE DATE OF THE PER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI TORQUE CONNECT GUIDEWIRE GUIDEWIRE DQX BRIVANT, LTD. 901022-02 10155638

    Patients

    Seq Age Sex Outcome Treatment
    1 Other