BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT GRAPHIX (TM)

    MDR report key: 2161508 · Received July 14, 2011

    Report

    Report Number
    2134265-2011-02719
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K950835
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: ONE DEVICE WAS RECEIVED WITH ITS ORIGINAL POUCH, OUTSIDE THE HOOP. DEVICE PRESENTS SEVERAL KINKS ALONG THE BODY. DISTAL TIP IS FRACTURED AT 180.3 CM FROM THE PROXIMAL END. KINKS AT 25 CM, 26.5 CM, 43 CM AND 62 CM FROM THE PROXIMAL END. ALL OUTER DIAMETER MEASUREMENTS ARE WITHIN SPECIFICATIONS. FAILURE OCCURED DUE TO A BENDING CYCLIC OVERLOAD. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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 INTERVENTION PROCEDURE A GUIDE WIRE FRACTURE OCCURRED. DURING A PERIPHERAL PROCEDURE OF THE LEFT POSTERIOR TIBIAL ARTERY, THE TIP OF THE GUIDE WIRE FRACTURED AND LODGED IN AN UNSPECIFIED ARTERY NEAR THE PATIENT'S HEEL. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT IS DOING WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL INTERVENTION PROCEDURE A GUIDE WIRE FRACTURE OCCURRED. DURING A PERIPHERAL PROCEDURE OF THE LEFT POSTERIOR TIBIAL ARTERY, THE TIP OF THE GUIDE WIRE FRACTURED AND LODGED IN AN UNSPECIFIED ARTERY NEAR THE PATIENT'S HEEL. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT IS DOING WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT GRAPHIX (TM) WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA H74914902011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other