BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSER CATHETER

    MDR report key: 4811537 · Received May 22, 2015

    Report

    Report Number
    2020394-2015-00802
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    November 24, 2014
    Report Date
    November 24, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K091119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FURTHER CLINICAL REVIEW WAS PERFORMED AND IDENTIFIED THIS EVENT TO BE MDR REPORTABLE PURSUANT TO 21 CFR PART 803. THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY EVENT REPORTED TO DATE FOR THIS LOT NUMBER AND FAILURE MODE. A MANUFACTURING REVIEW WAS CONDUCTED. THE LOT MET ALL RELEASE CRITERIA. THE SAMPLE WAS RETURNED CLEAN. THE DISTAL TIP WAS EXAMINED UNDER MAGNIFICATION (MICROSCOPE 10X) AND THE OUTER CATHETER WAS SEPARATED FROM THE DISTAL METAL TIP. AS A RESULT OF THE MATERIAL SEPARATION, THE METAL TIP WAS NOT ALIGNED WITH THE REST OF THE CATHETER. NO SIGNS OF TWISTING WERE NOTED ON THE OUTER CATHETER OR GUIDEWIRE LUMEN. NO OTHER ANOMALIES WERE NOTED ALONG THE LENGTH OF THE CATHETER. THE PATENCY OF THE GUIDEWIRE LUMEN WAS TESTED AND PASSED BOTH FRONT AND BACK LOADING TESTS WITH NO ISSUES. THE INVESTIGATION IS CONFIRMED FOR MATERIAL SEPARATION AS THE OUTER CATHETER HAD BECOME SEPARATED FROM THE METAL TIP. THE INVESTIGATION IS UNCONFIRMED FOR THE REPORTED GUIDEWIRE ISSUES, AS THE DEVICE PERFORMED PROPERLY UNDER LABORATORY CONDITIONS. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION. IT IS UNKNOWN IF PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED EVENT. SPECIFIC WARNINGS, PRECAUTIONS AND DIRECTIONS FOR USE OF THE CROSSER CATHETER ARE INCLUDED IN THE CURRENT INSTRUCTIONS FOR USE (IFU).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GUIDEWIRE WOULD NOT ADVANCE OUT OF THE DISTAL TIP OF TWO RECANALIZATION CATHETERS. ANOTHER RECANALIZATION CATHETER WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335332 CROSSER CATHETER DQY DQY BARD PERIPHERAL VASCULAR, INC. GFYG0445

    Patients

    Seq Age Sex Outcome Treatment
    1