BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBOHAWK PLAQUE EXCISION DEVICE

    MDR report key: 5152550 · Received October 15, 2015

    Report

    Report Number
    2183870-2015-07514
    Event Type
    Injury
    Date Received
    October 15, 2015
    Date of Event
    September 15, 2015
    Report Date
    September 15, 2015
    Manufacturer
    COVIDIEN
    Product Code
    MCW
    PMA / PMN Number
    K093301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED OCTOBER 26, 2015. IN ADDITION TO THE FACILITY NAME AND PHYSICIAN NAME: ON (B)(6) 2015 TWO STENTS WERE IMPLANTED. AFTER THAT THE EXPANSION OF THE VESSEL WAS GOOD. POST PROCEDURE ABI WAS RIGHT 0.94 / LEFT 0.97. THE PATIENT WAS DISCHARGED (B)(6) 2015 IN GOOD CONDITION.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PART OF A CLINICAL STUDY IN (B)(6). THE PATIENT WAS ADMITTED INTO THE HOSPITAL (B)(6) 2015 FOR PTA ON STENOSIS OF THE RIGHT MID-SFA AND THE SUBJECT WAS ENROLLED IN THE STUDY. ON (B)(6) 2015 ENDOVASCULAR THERAPY OF THE RIGHT SFA STENOSIS WHICH WAS 100% NON OR MILD-CALCIFIED WAS PERFORMED USING THE TURBOHAWK AND SPIDERFX. ON (B)(6) 2015 THE PATIENT WAS DISCHARGED. BY ULTRASOUND EXAMINATION, THE PHYSICIAN CONFIRMED THAT BLOOD FLOW SPEED WAS NOT INCREASING OBVIOUSLY. ABI: RIGHT 1.00 / LEFT 0.99. ON (B)(6) 2015 THE SUBJECT WAS DISCHARGED. ON (B)(6) 2015 AT THE 30 DAY FOLLOW UP THE ABI WAS RIGHT 0.98 / LEFT 0.91. BY ULTRASOUND EXAMINATION THE PHYSICIAN CONFIRMED THAT BLOOD FLOW SPEED WAS NOT INCREASING OBVIOUSLY. AT THE 180 DAY FOLLOW-UP THE ABI WAS RIGHT 0.64 / LEFT 0.91. BY ULTRASOUND EXAMINATION, THE PHYSICIAN DECIDED TO PERFORM EVT (ENDOVASCULAR THERAPY) BECAUSE THE TARGET LESION OF THE SFA WAS OCCLUDED COMPLETELY. ON (B)(6) 2015 THE SUBJECT WAS ADMITTED TO THE HOSPITAL FOR EVT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684475 TURBOHAWK PLAQUE EXCISION DEVICE CATHETER, PERIPHERAL, ATHERECTOMY MCW COVIDIEN THS-LS-C 9851218

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention