BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

    MDR report key: 3935934 · Received July 15, 2014

    Report

    Report Number
    2183870-2014-00178
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 18, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MCW
    PMA / PMN Number
    K103618
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THE REPORTED 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

    AS THE PHYSICIAN WAS CUTTING A SECOND SFA LESION, THE THUMBSWITCH OF THE TURBOHAWK WOULD NOT COMPLETELY TURN OFF. THIS WAS AFTER THE FIRST PASS, ON AN APPROXIMATELY 9-10CM CUT LENGTH IN A VERY TIGHT LESION. MINIMAL CALCIUM WAS APPRECIATED ON ANGIO. A PREVIOUS SFA LESION WAS TREATED BEFORE THIS LESION AND 4 PASSES WERE MADE WITH NO THUMBSWITCH TROUBLE. A SMALL PERFORATION WAS OBSERVED ON ANGIO AFTER FIRST LESION ATHERECTOMY. A BALLOON WAS INSERTED AND INFLATED. THE PERFORATION RESOLVED.

    Description of Event or Problem · 1

    THE TURBOHAWK DEVICE WAS RECEIVED FOR EVALUATION WITH THE CUTTER DRIVER (UNATTACHED) BUT WITHOUT ANY OTHER ANCILLARY DEVICES ASSOCIATED WITH THE PROCEDURE. NO OTHER ANCILLARY DEVICES OR CINE IMAGES FROM THE PROCEDURE WERE RECEIVED FOR EVALUATION. THERE WAS A NOTABLE KINK AT THE DISTAL EDGE OF THE TORQUE SHAFT HYPOTUBE COMPONENT. THE CUTTER HEAD ASSEMBLY WAS LOCATED IN THE DISTAL TIP ASSEMBLY HOUSING WINDOW. THE HANDLE ASSEMBLY WAS SEPARATED TO GAIN VISUAL ACCESS TO THE DRIVE SHAFT ASSEMBLY. THE DRIVE SHAFT COIL EXHIBITED A FRACTURE. THE FRACTURE LOCATION COINCIDES WITH THE DISTAL EDGE OF THE TORQUE SHAFT HYPOTUBE COMPONENT WHEN THE HANDLE WAS AT THE DISTAL EDGE OF ROTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413831 TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW COVIDIEN THS-LX-C 9859542

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention 6MM SPIDERFX