BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING

    MDR report key: 2133919 · Received June 20, 2011

    Report

    Report Number
    2134265-2011-02303
    Event Type
    Injury
    Date Received
    June 20, 2011
    Report Date
    May 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K945379
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: ANALYSIS OF THE RETURNED DEVICE REVEALED THE SPRING TIP WAS DETACHED. VISUAL AND TACTILE INSPECTION OF THE RETURNED DEVICE REVEALED THE CORE WIRE WAS FRACTURED 176.5CM FROM THE PROXIMAL END AND SEVERAL KINKS WERE IDENTIFIED. OUTER DIMENSIONS WHICH WERE TAKEN MET SPECIFICATIONS. SEM LAB ANALYSIS OF THE FRACTURED SECTION CONCLUDED THE FRACTURE OCCURRED DUE TO A TENSION OVERLOAD. 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 TREATMENT PROCEDURE, THE GUIDE WIRE "CAME APART". WHILE UTILIZING A PLATINUM PLUS GUIDE WIRE DURING PLACEMENT OF A NON BSC PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE, THE WIRE "CAME APART" INSIDE THE PICC AS IT WAS REMOVED. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT AND NO PATIENT COMPLICATIONS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL TREATMENT PROCEDURE, THE GUIDE WIRE "CAME APART". WHILE UTILIZING A PLATINUM PLUS GUIDE WIRE DURING PLACEMENT OF A NON BSC PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE, THE WIRE "CAME APART" INSIDE THE PICC AS IT WAS REMOVED. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT AND NO PATIENT COMPLICATIONS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA M001467310 13975859

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BARD POWER PICC