BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUEPATH¿

    MDR report key: 2831781 · Received November 14, 2012

    Report

    Report Number
    2134265-2012-07348
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    DQX
    PMA / PMN Number
    K101599
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    UPDATE - DEVICE EVALUATED BY MFR., METHOD CODES, RESULT CODES, CONCLUSION CODES. DEVICE EVALUATED BY MANUFACTURER - THE TRUEPATH UNIT WAS RETURNED FOR ANALYSIS WITH CONTROL UNIT AND WAS VISUALLY INSPECTED. THE DEVICE WAS FUNCTIONALLY TESTED AND IT WAS NOTED THAT THE TIP WAS NOT ROTATING. THE DEVICE WAS DISMANTLED AND THE DRIVE SHAFT WAS BROKEN. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL STENTING TREATMENT PROCEDURE, A VESSEL DISSECTION OCCURRED. THE 10CM TARGET LESION BEING TREATED WAS LOCATED IN THE HEAVILY CALCIFIED LEFT EXTERNAL ILIAC. THE PHYSICIAN HAD POPLITEAL ACCESS, COMING UP RETROGRADE. THE DEVICE DRILLED A TOTAL OF 10 MINUTES ABOUT 5 CM THROUGH THE OCCLUSION AND ENDED UP GOING SUB INTIMAL. LATER, NO FEEDBACK FROM THE DEVICE WAS NOTICED. THE DEVICE WAS REMOVED OUTSIDE THE PATIENT AND THE TIP WAS NO LONGER SPINNING. THE DRIVE SHAFT WAS BROKEN. HOWEVER, DISSECTION WAS NOTED. THE PHYSICIAN STOPPED THE PROCEDURE AND SURGERY CONSULTATION WAS NOTED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL STENTING TREATMENT PROCEDURE, A VESSEL DISSECTION OCCURRED. THE 10CM TARGET LESION BEING TREATED WAS LOCATED IN THE HEAVILY CALCIFIED LEFT EXTERNAL ILIAC. THE PHYSICIAN HAD POPLITEAL ACCESS, COMING UP RETROGRADE. THE DEVICE DRILLED A TOTAL OF 10 MINUTES ABOUT 5 CM THROUGH THE OCCLUSION AND ENDED UP GOING SUB INTIMAL. LATER, NO FEEDBACK FROM THE DEVICE WAS NOTICED. THE DEVICE WAS REMOVED OUTSIDE THE PATIENT AND THE TIP WAS NO LONGER SPINNING. THE DRIVE SHAFT WAS BROKEN. HOWEVER, DISSECTION WAS NOTED. THE PHYSICIAN STOPPED THE PROCEDURE AND SURGERY CONSULTATION WAS NOTED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUEPATH¿ WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - CORK H74939208181650 0012060801

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention