BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PT²¿

    MDR report key: 2870255 · Received December 12, 2012

    Report

    Report Number
    2134265-2012-07533
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    September 27, 2012
    Report Date
    November 13, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE RETURNED COMPLAINT DEVICE REVEALED DURING VISUAL INSPECTION TWO KINKS AT 180.5CM FROM THE PROXIMAL END AND AT 183.3CM FROM THE PROXIMAL END. ALSO, THE DEVICE IS PEELING ALONG THE BODY. THE DOWEL TEST WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE PTFE WAS PROPERLY ATTACHED TO THE GUIDEWIRE. DIMENSIONAL INSPECTION WAS PERFORMED AND ALL THE MEASURES TAKEN WERE WITHIN SPECIFICATIONS. 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 ANALYSIS COMPLETED ON (B)(4) 2012. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE, RESISTANCE DURING ADVANCEMENT OF THE GUIDE WIRE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING. AS THE 185CM STRAIGHT PT2 LIGHT SUPPORT GUIDE WIRE WAS BEING ADVANCED ACROSS THE LESION RESISTANCE WAS FELT. THE RESISTANCE DID NOT RESULT IN ANY REMOVAL DIFFICULTIES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE PTFE COATING IS PEELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT²¿ WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H74938931010 0014921587

    Patients

    Seq Age Sex Outcome Treatment
    1