BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBOHAWK ® PERIPHERAL PLAQUE EXCISION SYSTEM

    MDR report key: 3181782 · Received June 21, 2013

    Report

    Report Number
    2183870-2013-00154
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 24, 2013
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    PMA / PMN Number
    K103618
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 SUPPLEMENTAL 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

    RIGHT FEMORAL ACCESS, LEFT LEG ANGIOGRAM. THE PHYSICIAN REPORTED HEAVILY CALCIFIED VESSELS FROM THE COMMON FEMORAL DOWN TO THE TIBIALS. THE PHYSICIAN WIRED THE LESION TO BE TREATED IN THE PERONEAL, DEPLOYED A 4 MM EMBOLIC PROTECTION DEVICE, WIRED THE TURBOHAWK SSC OVER THE WIRE BUT COULD NOT CROSS THE LESION WITH THE TURBOHAWK SSC. THE PHYSICIAN REPORTED USING A LOT OF FORCE TO TRY AND CROSS, BUT WAS STILL UNSUCCESSFUL. THE PHYSICIAN REMOVED THE TURBOHAWK FROM THE PATIENT AND WENT BACK IN WITH AN .014 BALLOON TO TRY AND PREDIALATE THE LESION. AFTER THE PTA, THE PHYSICIAN WENT BACK IN WITH THE TURBOHAWK BUT WAS STILL UNSUCCESSFUL IN HIS EFFORTS TO CROSS THE LESION WITH THE DEVICE. WHILE PULLING THE TURBOHAWK SS-C OUT OF THE PATIENT, THE PHYSICIAN NOTED THAT THE DEVICE "LOOKED FUNNY." WHEN HE GOT TO THE TIP OF THE SHEATH, THE SSC GOT HUNG UP. THE PHYSICIAN TRIED TO PULL THE CATHETER BACK INTO THE SHEATH AT WHICH POINT THE TIP OF THE TURBOHAWK SS-C, AT THE POINT WHERE THE NOSECONE MEETS WITH THE CATHETER, BROKE OFF THE DEVICE AND BECAME LODGED IN THE PATIENTS COMMON FEMORAL ARTERY. THE PHYSICIAN PULLED THE SHEATH BACK, PREPPED THE LEFT GROIN AND PREFORMED A CUT DOWN PROCEDURE TO OPEN THE COMMON FEMORAL ARTERY SO AS TO REMOVE THE TIP, WHICH HE WAS ABLE TO SUCCESSFULLY REMOVE.

    Description of Event or Problem · 1

    DEVICE EVALUATION: TWO PHOTO IMAGES WERE PROVIDED FOR EVALUATION. THE FIRST IMAGE DOCUMENTS THAT TURBOHAWK DEVICE'S DISTAL TIP WEDGED OVER THE PROXIMAL MARKER BAND OF THE SPIDER FX FILTER ASSEMBLY. THE CORE WIRE OF THE SPIDER FX WAS LOOPED WITHIN THE FILTER MOUTH AND A BENT WIRE-LIKE OBJECT WAS NOTED OVER THE BODY OF THE DISTAL TIP ASSEMBLY. THE PROXIMAL END OF THE TIP ASSEMBLY BODY WAS SEPARATED (FRACTURED) AT THE HOUSING (NEAR THE THUMBSWITCH). THE SECOND IMAGE DOCUMENTS THE PROXIMAL END OF THE DISTAL TIP ASSEMBLY SEPARATED (FRACTURED) AT HOUSING. THE RESOLUTION OF THE EITHER IMAGE WAS NOT ADEQUATE TO ASCERTAIN THE FRACTURE MODE BETWEEN THE TO COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282204 TURBOHAWK ® PERIPHERAL PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW EV3 INC. THS-SS-C 9702146

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention 4MM SPIDERFX