BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING

    MDR report key: 2141647 · Received June 27, 2011

    Report

    Report Number
    2134265-2011-02377
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K945379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: ANALYSIS OF THE RETURNED DEVICE REVEALED A CORE WIRE FRACTURE 256.5CM APPROX. FROM THE PROXIMAL END AND A KINK LOCATED 256CM FROM THE PROXIMAL END. THE SPRING TIP WAS ELONGATED. THE OUTSIDE DIAMETER OF THE GUIDE WIRE WAS MEASURE AND FOUND TO BE WITHIN SPECIFICATION. MICROSCOPIC INSPECTION OF THE FRACTURE SITE REVEALED THAT THE FRACTURE OCCURRED DUE TO A TORSION OVERLOAD. NO MATERIAL ANOMALIES WERE NOTED. 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

    REPORTABLE BASED ON ADDITIONAL INFORMATION RECEIVED ON (B)(6), 2011. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A GUIDE WIRE DISTAL TIP KINKED OCCURRED THE 100% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT COMMON ILIAC ARTERY. AS THE PHYSICIAN ATTEMPTED TO ADVANCE THE PLATINUM PLUS GUIDE WIRE WITH HYDROPHILIC COATING TOWARDS THE LESION, THE DISTAL TIP OF THE PLATINUM PLUS GUIDE WIRE KINKED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC 12 GAUGE GUIDE WIRE WITH NO REPORTED PATIENT COMPLICATIONS. THE PATIENT'S STATUS POST PROCEDURE IS GOOD. DEVICE ANALYSIS REVEALED THAT THE CORE WIRE WAS FRACTURED 256.5CM FROM THE PROXIMAL END.

    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 M001467320 13727867

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDING INTRODUCER: 6FR TERUMO 25CM