BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSER RECANALIZATION CATHETER

    MDR report key: 4821533 · Received June 1, 2015

    Report

    Report Number
    2020394-2015-00854
    Event Type
    Malfunction
    Date Received
    June 1, 2015
    Date of Event
    February 19, 2015
    Report Date
    March 12, 2015
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K091119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO ENSURE COMPLIANCE TO 21 CFR 803.50 A RETROSPECTIVE REVIEW OF THIS FILE WAS CONDUCTED TO DETERMINE IF GOOD FAITH EFFORTS WERE MADE TO OBTAIN THE REQUIRED INFORMATION AND/OR AN EXPLANATION OF WHY ANY REQUIRED INFORMATION WAS NOT PROVIDED. THIS FILE INDICATED ATTEMPTS WERE MADE TO THE FACILITY TO OBTAIN INFORMATION PERTAINING TO PATIENT, PRODUCT, AND/OR PROCEDURAL DETAILS (E.G. DATE OF THE EVENT, RELEVANT TEST DATA, RELEVANT HISTORY, LOT #, CATALOG #, IMPLANT AND/OR EXPLANTED DATES, AND CONCOMITANT PRODUCT(S) OR THERAPY). THE FILE WAS DOCUMENTED WITH DEVICE AND PATIENT CODES, BUT NOT REPORTED. ALL OTHER REQUIRED INFORMATION WAS PREVIOUSLY PROVIDED AND NO FURTHER FOLLOW UP ATTEMPTS WERE COMPLETED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING REVIEW WAS CONDUCTED. THE LOT MET ALL RELEASE CRITERIA. THE DEVICE WAS RETURNED. PRODUCT PACKAGING AND LABEL WERE NOT RETURNED. A COMPLETE CIRCUMFERENTIAL BREAK IN THE Y-CONNECTOR WAS NOTED NEAR THE DISTAL END OF THE Y-CONNECTOR. THE CROSSER HANDLE WAS ABLE TO BE CONNECTED TO THE TRANSDUCER OF THE IN-HOUSE GENERATOR WITHOUT ISSUE. NO FURTHER FUNCTIONAL TESTING COULD BE PERFORMED BASED UPON THE CONDITION OF THE RETURNED SAMPLE. THE INVESTIGATION IS CONFIRMED FOR A BROKEN Y-CONNECTOR. THE INVESTIGATION IS UNCONFIRMED FOR A CONNECTION ISSUE BETWEEN THE CROSSER HANDLE AND THE TRANSDUCER AS THE CROSSER HANDLE WAS ABLE TO CONNECT TO AN IN-HOUSE TRANSDUCER WITHOUT ISSUE. IT IS UNK WHETHER THE MANNER IN WHICH THE DEVICE WAS UNSNAPPED FROM THE PACKAGING HOOP CONTRIBUTED TO THE BREAK IN THE Y-CONNECTOR. IT IS UNK WHETHER PROCEDURAL ISSUE OR THE USER'S TRANSDUCER CONTRIBUTED TO THE REPORTED CONNECTION ISSUE. BASED UPON THE AVAILABLE INFO, THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE CROSSER CATHETER IFU PROVIDES GENERAL INSTRUCTIONS FOR USE OF THE DEVICE, AS WELL AS WARNINGS, PRECAUTIONS, AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RECANALIZATION CATHETER COULD NOT BE ATTACHED TO THE TRANSDUCER. ANOTHER CATHETER WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351928 CROSSER RECANALIZATION CATHETER DQY DQY BARD PERIPHERAL VASCULAR, INC. GFYJ3060

    Patients

    Seq Age Sex Outcome Treatment
    1