BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAUNCHER 6F GUIDE CATHETER

    MDR report key: 4168643 · Received October 14, 2014

    Report

    Report Number
    1220452-2014-00063
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    February 20, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DQY
    PMA / PMN Number
    K021256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: RELATED TO OPERATIONAL CONTEXT (COMPLEX PROCEDURE WITH MULTIPLE DEVICES BEING USED). CONCLUSION: OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THE EVENT (COMPLEX PROCEDURE WITH MULTIPLE DEVICES BEING USED). (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING A PRESSURE FLOW WIRE PROCEDURE, PERFORMED THROUGH A 6 F JR 4.0 W/SH LAUNCHER GUIDE WITH A NON-MEDTRONIC WIRE, THE WIRE PASSED THROUGH A SIDE HOLE IN THE GUIDE CATHETER PAST THE TRANSDUCER. THE WIRE COULD NOT BE PULLED BACK INTO THE GUIDE CATHETER AS THE TRANSDUCER LODGED ON THE OUTSIDE OF THE SIDE HOLE. WHEN TRYING TO REMOVE THE WIRE, IT GOT CAUGHT ON THE SENSOR AND RIPPED THE WIRE APART. GUIDE AND WIRE WERE REMOVED TOGETHER AND A NEW NON-MEDTRONIC WIRE WAS AGAIN PLACED INTO THE PATIENT WHERE THE WIRE ONCE AGAIN WENT THROUGH THE SIDE HOLE AND BECAME STUCK. THE LAUNCHER AND THE WIRE WERE REMOVED TOGETHER. GUIDE AND WIRE WERE ADVANCED AND WITH GREAT CARE THE SIDE HOLE WAS AVOIDED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO PATIENT HARM WAS REPORTED BUT THE PROCEDURE WAS PROLONGED. EVALUATION SUMMARY: RECEIVED FOR EVALUATION WAS ONE 6F JR40 LAUNCHER GUIDE CATHETER COILED UP IN A BIO BAG WITH ORIGINAL PACKAGING. CLOSER VISUAL INSPECTION NOTED DAMAGE TO THE SIDE HOLE. THE CATHETER EXHIBITED A SEVERE KINK ON THE PROXIMAL SIDE HOLE AND ALSO A SIGNIFICANT CRUSHED SECTION 1CM FROM THE TIP. SIDE HOLES WERE ALIGNED WITH THE CURVE AND MEASUREMENTS WERE FOUND TO BE WITHIN SPECS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651817 LAUNCHER 6F GUIDE CATHETER CATHETER, PERCUTANEOUS DQY MEDTRONIC, INC 0006973974

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR