BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BTK TURBOHAWK

    MDR report key: 5205409 · Received November 5, 2015

    Report

    Report Number
    2183870-2015-07532
    Event Type
    Injury
    Date Received
    November 5, 2015
    Date of Event
    October 9, 2015
    Report Date
    October 9, 2015
    Manufacturer
    COVIDIEN, LLN
    Product Code
    MCW
    PMA / PMN Number
    K103618
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    AN ATHERECTOMY OF RIGHT COMMON FEMORAL ARTERY THROUGH RIGHT BRACHIAL APPROACH WAS PERFORMED USING A 7FR. 90CM TERUMO SHEATH. PREDILATATION WAS COMPLETED WITH A 2.0X100 POWERCROSS BALLOON AND THEN WITH A 4.0 X 60 ADMIRAL BALLOON. THE VESSEL WAS VERY CALCIFIED WITH A SUBTOTAL OCCLUSION AND THE PHYSICIAN WAS ABLE TO CROSS LESION. THE SPIDER WIRE WAS PLACED AND THE TURBOHAWK CATHETER WAS UTILIZED MAKING MANY PASSES. UPON REMOVAL OF THE TURBOHAWK DEVICE, THE PHYSICIAN REALIZED THERE WAS A LOOP IN THE SPIDER WIRE. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE TURBOHAWK THROUGH THE SHEATH. IN DOING SO, HE MET RESISTANCE AND THE NOSE OF THE TURBOHAWK CAME APART FROM THE DEVICE LEAVING IT STILL ON THE SPIDER WIRE. A SNARE WAS USED AND THE TIP WAS REMOVED FROM THE PATIENT. INVESTIGATION OF THE COMPLAINT ON (B)(6) 2015, CONFIRMED THE CUSTOMER'S COMPLAINT. THE CUSTOMER'S REPORT OF THE TURBOHAWK NOSECONE SEPARATION WHILE ON THE SPIDER FX WAS CONFIRMED. PROCEDURE NOTES PROVIDED BY THE CUSTOMER INCLUDES THE REPORTED COMPLICATION WHERE THE TURBOHAWK BROKE OFF AND SEPARATED FROM THE FILTER WIRE� THERE WAS NO INDICATION ANY COMPONENTS WERE MISSING UPON VISUAL INSPECTION ON ALL THREE UNITS. THE ROOT CAUSE OF THE REPORTED ISSUE OF THE BROKEN TIP OF THE TURBOHAWK WHILE IN USE WITH THE SPIDER FX HAS BEEN IDENTIFIED. THE USER EXPERIENCED GUIDE WIRE PROLAPSE DURING REMOVAL OF THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736194 BTK TURBOHAWK CATHETER, PERIPHERAL, ATHERECTOMY MCW COVIDIEN, LLN THS-SX-C A051426

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Required Intervention