BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BTK TURBOHAWK

    MDR report key: 4570584 · Received March 4, 2015

    Report

    Report Number
    2183870-2015-00061
    Event Type
    Injury
    Date Received
    March 4, 2015
    Date of Event
    February 2, 2015
    Report Date
    February 2, 2015
    Manufacturer
    COVIDIEN
    Product Code
    MCW
    PMA / PMN Number
    K103618
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT.

    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.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE TURBOHAWK DEVICE WAS RECEIVED WITHOUT THE CUTTER DRIVER BUT WITH A 6FR GUIDE SHEATH AND A 0.014 SPIDER FX CAPTURE WIRE. THE TURBOHAWK RX GUIDEWIRE LUMEN (GWL) WAS TORN LONGITUDINALLY FROM THE PROXIMAL EDGE TO THE PROXIMAL END OF THE TAPERED TIP WHERE THE GWL BECOMES DEEPLY ENCAPSULATED INTO THE MOLDED TECOTHANE MATERIAL. THE DISTAL END OF THE CAPTURE WIRE (THE FILTER) HAD BEEN CUT OFF AND EXHIBITED SEVERAL BENDS AND A TWIST PROXIMAL TO THE TORN TURBOHAWK GWL.

    Description of Event or Problem · 1

    DEVICE DID NOT CROSS THE FEMORAL LESION, PRE-DILATATION WITH 2MM BALLOON WAS PERFORMED, AND THE DEVICE STILL DID NOT CROSS, THEREFORE THE PHYSICIAN DILATED WITH A 3MM BALLOON. THE TURBOHAWK DEVICE WAS THEN ABLE TO CROSS THE LESION. FOUR PASSES WERE MADE IN DIFFERENT QUADRANTS AND THE TREATMENT WAS COMPLETED. THE TURBOHAWK WAS THEN PULLED BACK, BUT IT BECAME STUCK AT THE DISTAL END OF THE 6F SHEATH. THE PHYSICIAN THEN NOTICED A "LOOP" OR KNOT IN THE SPIDERFX WIRE. A SNARE WAS INSERTED TO REMOVE THE SPIDER FILTER BASKET. THE PHYSICIAN THEN REMOVED ALL REMAINING DEVICES TOGETHER AT THE SAME TIME (THE TURBOHAWK, REMAINING SPIDER WIRE AND 6F SHEATH). PLEASE REFERENCE MDR 2183870-2015-00062 FOR THE SPIDERFX USED IN THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151335 BTK TURBOHAWK ATHERECTOMY PERIPHERAL CATHETER MCW COVIDIEN THS-SX-C 9961838

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other