BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPROACH HYDRO ST MICROWIRE WIRE GUIDE

    MDR report key: 4912569 · Received July 7, 2015

    Report

    Report Number
    1820334-2015-00430
    Event Type
    Injury
    Date Received
    July 7, 2015
    Date of Event
    February 13, 2015
    Report Date
    June 10, 2015
    Manufacturer
    COOK INC
    Product Code
    DXQ
    PMA / PMN Number
    K091385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). **** EVENT EVALUATION **** THE PRODUCT WAS NOT RETURNED; THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE PERFORMED. THE LOT RECORDS OF THE DEVICE WERE REVIEWED; WHICH DETERMINED THAT THERE WERE NO ISSUES CONCERNING THE QUALITY OF THE PRODUCT, RELATIVE TO THIS INVESTIGATION. PER SPECIFICATION, QUALITY CONTROL PERSONNEL PERFORMS A 100% INSPECTION, VERIFYING EACH DEVICE IS FREE FROM BENDS, KINKS, ADEQUATE JOINT STRENGTH, CORRECT OUTSIDE DIMENSION AND OTHER SURFACE IMPERFECTIONS, DURING MANUFACTURING AND AGAIN, PRIOR TO TRANSPORT. RELATIVE TO THIS FAILURE MODE THE INSTRUCTIONS FOR USE STATES: 1. "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." 2. "CAREFULLY REMOVE THE WIRE GUIDE FROM THE HOLDER." 3. "IF DESIRED, WIRE GUIDE TIP MAY BE CAREFULLY SHAPED USING STANDARD TIP SHAPING TECHNIQUES. DO NOT USE A SHAPING INSTRUMENT WITH A SHARP EDGE. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE CAN NOT BE DETERMINED OR REPORTED AT THIS TIME. WE ARE CONTINUING TO MONITOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL OF THIS EVENT.

    Description of Event or Problem · 1

    DURING A SUBINTIMAL ANGIOPLASTY OF THE POSTERIOR TIBIAL ARTERY OCCLUSION, THE TIP OF GUIDEWIRE USED TO CROSS LESION BROKE AND COULD NOT BE RETRIEVED FROM THE PATIENT. ADDITIONAL INFORMATION RECEIVED 06/26/2015: WHILST IN SUB INTIMAL PLAIN OF THE AT THE CONSULTANT MANAGED TO BREAK BACK IN WITH THE 0.14 HYDRO AND CXI CATH. HOWEVER THE USER WAS UNABLE TO PROGRESS ANY FURTHER WITH THE APPROACH HYDRO ST MICROWIRE WIRE GUIDE, AT THIS POINT THE USER WITHDREW THE WIRE WHICH RESULTED IN THE WIRE FRAYING AND THE TIP BECOMING DETACHED DISTAL TO THE OCCLUSION. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE DETACHED PART OF THE WIRE. IT WAS DECIDED TO ATTEMPT A DIFFERENT APPROACH TO REVASCULARIZE THE AREA OF THE FOOT WHICH REQUIRED TREATMENT. THIS APPROACH WORKED AND THE PATIENT OUTCOME WAS SATISFACTORY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    DURING A SUBINTIMAL ANGIOPLASTY OF THE POSTERIOR TIBIAL ARTERY OCCLUSION, THE TIP OF GUIDEWIRE USED TO CROSS LESION BROKE AND COULD NOT BE RETRIEVED FROM THE PATIENT. ADDITIONAL INFORMATION RECEIVED 26JUNE2015: WHILST IN SUB INTIMAL PLAIN OF THE AT, THE CONSULTANT MANAGED TO BREAK BACK IN WITH THE 0.14 HYDRO AND CXI CATH. HOWEVER, THE USER WAS UNABLE TO PROGRESS ANY FURTHER WITH THE COOK HYDRO ST MICROWIRE WIRE GUIDE. AT THIS POINT THE USER WITHDREW THE WIRE; WHICH RESULTED IN THE WIRE FRAYING AND THE TIP DETACHED, DISTAL TO THE OCCLUSION. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE DETACHED PART OF THE WIRE. IT WAS DECIDED TO ATTEMPT A DIFFERENT APPROACH, TO REVASCULARIZE THE AREA OF THE FOOT WHICH REQUIRED TREATMENT. THIS APPROACH WORKED AND PATIENT OUTCOME WAS SATISFACTORY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437734 APPROACH HYDRO ST MICROWIRE WIRE GUIDE DQX WIRE, GUIDE, CATHETER DXQ COOK INC N/A 5495767

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention