BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPROACH CTO MICROWIRE WIRE GUIDE

    MDR report key: 2800409 · Received October 16, 2012

    Report

    Report Number
    1820334-2012-00477
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 27, 2012
    Manufacturer
    COOK INC.
    Product Code
    DQX
    PMA / PMN Number
    K081337
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT WAS RETURNED IN A USED AND DAMAGED CONDITION. THIS DEVICE IS PURCHASED FROM A VENDOR. IT IS INSPECTED PER QC WHICH VERIFIES THE COATED CORE WIRE OUTSIDE DIAMETER, APPROPRIATE COIL AND CORE WIRE MATERIAL, SPECIFIED LENGTH OF OVERALL GUIDE, SUFFICIENT SOLDER FLOW AT JOINTS ARE SECURE, THAT GAGE WILL PASS THROUGH SPECIFIED GAGE, COATED SURFACE IS FREE OF DEFECTS END IS ROUNDED SMOOTH, VERIFY COATING IS SMOOTH WITHOUT RUINS, PEELING OR FLAKING OF THE COATING, TORQUE TEST TO ENSURE GUIDE WILL NOT "WHIP" OR "JUMP" WHEN ROTATED 360 DEGREES. AN EXAMINATION OF THE RETURNED WIRE GUIDE DID NOT PROVIDE ANY EVIDENCE FOR A ROOT CAUSE. IN PREVIOUS COMPLAINTS WE HAVE FOUND POSSIBLE CAUSES TO INCLUDE DAMAGE TO THE WIRE GUIDE ASSOCIATED WITH WITHDRAWAL THROUGH THE NEEDLE (PER WARNING TABLE) OR OTHER INSTRUMENT. LESS FREQUENTLY, PT ANATOMY MAKES WITHDRAWAL OF THE WIRE GUIDE DIFFICULT IN SEPARATION WHEN THE FORCE EXCEEDS DESIGN SPEC. ONCE THE TIP WAS 'EMBEDDED INTO THE OCCLUSION" THE FORCE TO WITHDRAW EXCEEDED THE DESIGN OF THE DEVICE. IN THE ABSENCE OF ANY DETAIL CONCERNING THIS COMPLAINT THE ROOT CAUSE CANNOT BE DETERMINED. ROOT CAUSE IS INCONCLUSIVE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. NO ACTIONS ARE NECESSARY AT THIS TIME AS THERE IS INSUFFICIENT RISK PER QUALITY ENGINEERING RISK ASSESSMENT.

    Description of Event or Problem · 1

    THE WIRE WAS ADVANCED INTO A CTO. THE TIP OF THE WIRE GOT EMBEDDED INTO THE OCCLUSION AND CAME UNRAVELED. WHEN THE WIRE WAS REMOVED, IT WAS NOTICED THAT THE TIP OF THE WIRE MISSING. (THE TIP OF THE WIRE REMAINED INSIDE THE PT). PER SALES REP, THE PHYSICIAN IS NOT GOING TO PERFORM ANY ADD'L PROCEDURES TO REMOVE THE EMBEDDED WIRE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APPROACH CTO MICROWIRE WIRE GUIDE DQX, WIRE, GUIDE, CATHETER DQX COOK INC. NA 3601364

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other