BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PT GRAPHIX¿

    MDR report key: 2802909 · Received October 24, 2012

    Report

    Report Number
    2134265-2012-06414
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 27, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K950835
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR ANALYSIS. THE DEVICE WAS CUT IN TWO SECTIONS, THE PROXIMAL SECTION PRESENTS A KINK AT 27.2 FOM THE PROXIMAL END, AND THE DISTAL SECTION PRESENTS TWO KINKS AT 39CM AND 151CM FROM THE PROXIMAL END. ALL THE MEASURES TAKEN DURING DIMENSIONAL INSPECTION ARE WITHIN SPECIFICATIONS. THE RETURNED DEVICE WAS SENT FOR EXTERNAL ANALYSIS ((B)(4) LAB) TO DETERMINE THE FRACTURE FAILURE MODE. THE FAILURE OCCURRED DUE TO A TENSION/BENDING OVERLOAD WITH A FINAL TORSION EVENT. THE FAILURE WAS DUE TO A TENSION/BENDING 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) WIRE BREAKAGE OCCURRED. A PT GRAPHIX GUIDE WIRE WAS USED WITH AN UNKNOWN BALLOON CATHETER. WHEN THE PHYSICIAN WANTED TO CHANGE THE BALLOON ON THE PT GRAPHIX WIRE, THE WIRE BROKE. THE EVENT OCCURRED OUTSIDE THE PATIENT. NO PATIENT COMPLICATION WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), WIRE BREAKAGE OCCURRED. A PT GRAPHIX GUIDE WIRE WAS USED WITH AN UNKNOWN BALLOON CATHETER. WHEN THE PHYSICIAN WANTED TO CHANGE THE BALLOON ON THE PT GRAPHIX WIRE, THE WIRE BROKE. THE EVENT OCCURRED OUTSIDE THE PATIENT. NO PATIENT COMPLICATION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT GRAPHIX¿ WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H7491490201J1 15296738

    Patients

    Seq Age Sex Outcome Treatment
    1