BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAIGA 6F GUIDE CATHETER

    MDR report key: 3982575 · Received August 6, 2014

    Report

    Report Number
    1220452-2014-00051
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    April 24, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DQY
    PMA / PMN Number
    K083422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: DEFORMATION PROBLEM; RELATED TO ANOTHER DRUG/DEVICE (COMPETITOR GUIDE WIRE). CONCLUSION: ANOTHER DEVICE CAUSED FAILURE (COMPETITOR GUIDE WIRE). (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING A PROCEDURE FOR THE TREATMENT OF A LESION IN THE RCA, WHEN THE PHYSICIAN ATTEMPTED TO DELIVER A NON-MEDTRONIC GUIDEWIRE THROUGH A TA6JR40SH GUIDE CATHETER, RESISTANCE WAS ENCOUNTERED. ALTHOUGH THE PHYSICIAN ATTEMPTED TO WITHDRAW THE GUIDEWIRE, IT WAS NOT POSSIBLE. THE GUIDEWIRE AND THE GUIDE CATHETER WERE WITHDRAWN TOGETHER AND IT WAS CONFIRMED THAT THE GUIDEWIRE PASSED THROUGH THE SIDE HOLE OF THE GUIDE CATHETER. IT IS UNKNOWN IF THE DEVICE WAS INSPECTED PRIOR TO USE BUT NO ABNORMALITIES WERE REPORTED. IT IS REPORTED THAT FORCE WAS NOT APPLIED IN AN ATTEMPT TO ADVANCE THE WIRE. THE OPERATION WAS COMPLETED USING ANOTHER DEVICE (DETAIL UNKNOWN) AS REPLACEMENT. NO HEALTH HAZARD OCCURRED TO THE PATIENT. EVALUATION SUMMARY: GUIDE CATHETER AND THE COMPETITOR GUIDE WIRE (ENGAGED TO THE CATHETER) WERE RETURNED FOR EVALUATION. THE GUIDE WIRE EXITED THE GUIDE CATHETER THROUGH THE PROXIMAL SIDE HOLE. 8 CM OF THE WIRE EXITED THROUGH THE SIDE HOLE, WITH 73.7CM OUT OF THE HUB. CLOSER VISUAL INSPECTION NOTED DAMAGE TO THE OUTER JACKET AROUND THE PROXIMAL SIDE HOLE WITH ONE OF THE BRAID WIRES OUT OF THE OUTER JACKET. THE SIDE HOLES MEASUREMENTS WERE WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461448 TAIGA 6F GUIDE CATHETER CATHETER, PERCUTANEOUS DQY MEDTRONIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1