BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM PLUS¿

    MDR report key: 2347225 · Received November 23, 2011

    Report

    Report Number
    2134265-2011-05182
    Event Type
    Malfunction
    Date Received
    November 23, 2011
    Date of Event
    November 2, 2011
    Report Date
    November 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K945379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ONE DEVICE WAS RECEIVED AND VISUAL INSPECTION WAS PERFORMED. THE ENTIRE LENGTH OF THE WIRE WAS EXAMINED AND ANOMALIES WERE OBSERVED. THE DEVICE PRESENTS THE SPRING TIP SLIGHTLY ELONGATED AT 5 MM FROM THE DISTAL TIP SECTION, ADDITIONALLY THE DEVICE PRESENTS A KINK IN THAT SAME AREA. THE DEVICE ALSO PRESENTS THE COATING SCRAPED (PEELED) ALONG THE ENTIRE BODY. THE DEVICE APPEARS TO HAVE BEEN PULLED AGAINST RESISTANCE. THE OUTER DIAMETER MEASURED IN DAMAGED AREAS MET SPECIFICATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING UNPACKING FOR A DIALYSIS ACCESS MANAGEMENT PROCEDURE A GUIDEWIRE TIP BREAK OCCURRED. A PLATINUM PLUS-3 018/180 GUIDEWIRE WAS BEING OPENED IN PREPARATION OF A DIALYSIS MANAGEMENT PROCEDURE WHEN IT WAS NOTICED THAT THE TIP OF THE GUIDEWIRE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING UNPACKING FOR A DIALYSIS ACCESS MANAGEMENT PROCEDURE A GUIDEWIRE TIP BREAK OCCURRED. A PLATINUM PLUS-3 018/180 GUIDEWIRE WAS BEING OPENED IN PREPARATION OF A DIALYSIS MANAGEMENT PROCEDURE WHEN IT WAS NOTICED THAT THE TIP OF THE GUIDEWIRE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATINUM PLUS¿ WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA M001466040 14436797

    Patients

    Seq Age Sex Outcome Treatment
    1