BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPROACH HYDRO ST MICROWIRE WIRE GUIDE

    MDR report key: 4909821 · Received July 9, 2015

    Report

    Report Number
    1820334-2015-00429
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    June 9, 2015
    Report Date
    June 9, 2015
    Manufacturer
    COOK INC
    Product Code
    DXQ
    PMA / PMN Number
    K091385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVALUATION: A REVIEW OF COMPLAINT HISTORY, DOCUMENTATION, DRAWING, MANUFACTURING INSTRUCTIONS, INSTRUCTIONS FOR USE (IFU), SPECIFICATIONS AND A VISUAL INSPECTION WAS CONDUCTED DURING THE INVESTIGATION. ONE MICROWIRE GUIDE WAS RETURNED IN A USED CONDITION. THE RETURNED DEVICE WAS EXAMINED; WHICH REVEALED THAT A KINK WAS NOTED APPROXIMATELY 1.75 CENTIMETERS FROM THE DISTAL END. THE LOT RECORDS OF THE DEVICE WERE REVIEWED. NO ISSUES CONCERNING THE QUALITY OF THE PRODUCT RELATIVE TO THIS INVESTIGATION WERE NOTED. THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS OUT OF SPECIFICATION. RELATIVE TO THIS FAILURE MODE THE IFU STATES: "FLUSH THE WIRE GUIDE HOLDER BY ATTACHING OR PRESSING A SYRINGE WITH HEPARINIZED SALINE OR STERILE WATER TO THE FITTING OF THE WIRE GUIDE HOLDER AND INJECTING ENOUGH SOLUTION TO WET THE WIRE GUIDE SURFACE ENTIRELY." "CAREFULLY REMOVE THE WIRE GUIDE FROM THE HOLDER." "IF DESIRED, WIRE GUIDE TIP MAY BE CAREFULLY SHAPED USING STANDARD TIP SHAPING TECHNIQUES. DO NOT USE A SHAPING INSTRUMENT WITH A SHARP EDGE. IT WAS REPORTED THAT THIS INCIDENT RESULTED IN LOW IMPACT TO THE PATIENT. QUALITY ENGINEERING RISK ASSESSMENT WAS USED TO ASSESS THE RISK FOR THIS FAILURE MODE. THERE IS INSUFFICIENT RISK TO WARRANT RISK REDUCTION ACTIVITIES. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    DURING A LEFT LEG ANGIOGRAM ON A (B)(6) FEMALE PATIENT, THE TIP OF THE HYDRO ST WIRE BROKE OFF IN THE PATIENT'S 1.5MM PERONEAL ARTERY. THE PHYSICIAN USED ANOTHER MANUFACTURER'S ROTATIONAL ATHERECTOMY DEVICE (SIZE 1.50) TO GRIND THE BROKEN WIRE PIECE. NO VISIBLE PIECES WERE LEFT AFTER ATHERECTOMY DEVICE WAS USED. ACCORDING TO THE REPORTER, BESIDES DISCOMFORT WHILE THE ATHERECTOMY DEVICE WAS BEING USED TO GRIND THE WIRE, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    DURING A LEFT LEG ANGIOGRAM ON A (B)(6) YEAR OLD FEMALE PATIENT, THE TIP OF THE HYDRO ST WIRE BROKE OFF IN THE PATIENT'S 1.5MM PERONEAL ARTERY. THE PHYSICIAN USED ANOTHER MANUFACTURER'S ROTATIONAL ATHERECTOMY DEVICE (SIZE 1.50) TO GRIND THE BROKEN WIRE PIECE. NO VISIBLE PIECES WERE LEFT AFTER ATHERECTOMY DEVICE WAS USED. ACCORDING TO THE REPORTER, BESIDES DISCOMFORT WHILE THE ATHERECTOMY DEVICE WAS BEING USED TO GRIND THE WIRE, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444748 APPROACH HYDRO ST MICROWIRE WIRE GUIDE DQX WIRE, GUIDE, CATHETER DXQ COOK INC N/A 5854670

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention