BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATK TURBOHAWK

    MDR report key: 5224792 · Received November 16, 2015

    Report

    Report Number
    2183870-2015-00457
    Event Type
    Malfunction
    Date Received
    November 16, 2015
    Date of Event
    April 10, 2015
    Report Date
    April 10, 2015
    Manufacturer
    COVIDIEN
    Product Code
    MCW
    PMA / PMN Number
    K103618
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN (B)(4) LOCATION, FOLLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN. A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING. (B)(4).

    Description of Event or Problem · 1

    EVENT DESCRIPTION: IT WAS REPORTED THAT IT WAS VERY DIFFICULT TO INSERT AND PUSH THE TURBOHAWK THROUGH THE SHEATH DURING TREATMENT. PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE, NO PATIENT INJURY REPORTED. DEVICE EVALUATION: THE TURBOHAWK LX-C DEVICE WAS INSPECTED AND FOUND NO DAMAGES OR ANOMALIES THAT WOULD APPEAR TO HAVE CONTRIBUTED TO THE REPORTED EVENT. THE SHEATH WAS INSPECTED AND NO KINKS WERE FOUND. THE SHEATH WAS FLUSHED WITH WATER AND THE TURBOHAWK SX-C WAS INSERTED. NO RESISTANCE WAS NOTED. THEN THE TURBOHAWK LX-C WAS INSERTED AND WAS ABLE TO EXIT THE DISTAL PORT. MINIMAL RESISTANCE WAS OBSERVED. A 0.014" GUIDEWIRE FROM THE LAB WAS INSERTED AND THE DIAMETER OF THE DISTAL ASSEMBLY WAS MEASURED. THE PROXIMAL TIP MUST NOT EXCEED 0.1054". THE MEASUREMENT OF THE DISTAL SECTION IS 0.099", MEDIAL IS 0.101", AND PROXIMAL IS 0.10". THE DISTAL ASSEMBLY DIAMETER WAS WITHIN SPECIFICATION. GREEN MATERIAL WAS OBSERVED AROUND THE CUTTER HEAD. THE LUBRICIOUS COATING OF THE TURBOHAWK LX-C DEVICE WAS NOT CONSISTENT THROUGH THE ENTIRE DEVICE. THE RECEIVED SHEATH WAS COMPARED WITH A SHEATH FROM THE R+D LAB, WHICH WAS THE SAME BRAND AS THE SHEATH IN QUESTION. COATING INTEGRITY TEST COATING IN MIDDLE SECTION UNTIL 19CM FROM TIP. TIP FEELS COATED. SHEATH CAME WITH DILATER INSERTED. DISTAL END: CAN FEEL EACH WIND OF COIL STARTING AT 0.0945" CAN PUSH IN PIN UP TO 0.0985". PROXIMAL END (NOT HUB): 0.0005". HUB: 0.01005". CONTROL DEVICE: H1-LX UNIT #2 FROM CHARACTERIZED WORK. FILLED DFT WITH WATER WET DEVICE AND SLID DFT DISTALLY UNTIL STOP AND THEN PROXIMALLY TO STRAIN RELIEF. FUNCTIONAL TESTING WITH CONTROL TURBOHAWK LX-C DEVICE FROM R+D WAS PERFORMED. AFTER MULTIPLE INSERTIONS AND COMPARING THE CONTROL SHEATH TO THE RETURNED SHEATH, IT WAS FOUND RESISTANCE WAS FELT WHEN ENCOUNTERING A CURVE OR BEND IN THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757921 ATK TURBOHAWK CATHETER PERIPHERAL ATHERECTOMY MCW COVIDIEN THS-LX-C A058009

    Patients

    Seq Age Sex Outcome Treatment
    1