BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT GRAPHIX (TM)

    MDR report key: 2235288 · Received September 6, 2011

    Report

    Report Number
    2134265-2011-03714
    Event Type
    Injury
    Date Received
    September 6, 2011
    Date of Event
    June 13, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    DQX
    PMA / PMN Number
    K950835
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2011-03713. IT WAS REPORTED ON A (B)(4), THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), A WIRE FRACTURE OCCURRED. AN 80% STENOSED LESION LOCATED IN THE PROXIMAL LEFT MAIN (LM) ARTERY AND AN 80% STENOSED LESION IN THE DISTAL CIRCUMFLEX (CX) ARTERY WERE BEING TREATED. THE ANGLE THROUGH LM INTO THE CX WAS EXTREMELY ACUTE BUT THE PHYSICIAN WAS ABLE TO PLACE A GUIDE WIRE IN THE PROXIMAL CX. DURING ONE OF THE WIRE EXCHANGES, A PT GRAPHIX GUIDE WIRE EXITED THE WIRE LUMEN INTO THE 1.5X15MM APEX BALLOON LUMEN AND PART OF THE GUIDE WIRE FRAGMENTED FROM THE VERY TIP OF THE SYSTEM LEAVING TWO PIECES INTRA CORONARY. ATTEMPTS TO REMOVE THE FRAGMENTS WERE UNSUCCESSFUL. UPON EXAMINATION, A HOLE WAS IDENTIFIED IN THE APEX BALLOON. THE BALLOON HAD BEEN INFLATED TO 12ATM. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE/DISCHARGED HOME.

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2011-03713. IT WAS REPORTED ON A USER FACILITY MEDWATCH REPORT 459934 5021470, THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), A WIRE FRACTURE OCCURRED. AN 80% STENOSED LESION LOCATED IN THE PROXIMAL LEFT MAIN (LM) ARTERY AND AN 80% STENOSED LESION IN THE DISTAL CIRCUMFLEX (CX) ARTERY WERE BEING TREATED. THE ANGLE THROUGH LM INTO THE CX WAS EXTREMELY ACUTE BUT THE PHYSICIAN WAS ABLE TO PLACE A GUIDE WIRE IN THE PROXIMAL CX. DURING ONE OF THE WIRE EXCHANGES, A PT GRAPHIX GUIDE WIRE EXITED THE WIRE LUMEN INTO THE 1.5X15MM APEX BALLOON LUMEN AND PART OF THE GUIDE WIRE FRAGMENTED FROM THE VERY TIP OF THE SYSTEM LEAVING TWO PIECES INTRA CORONARY. ATTEMPTS TO REMOVE THE FRAGMENTS WERE UNSUCCESSFUL. UPON EXAMINATION, A HOLE WAS IDENTIFIED IN THE APEX BALLOON. THE BALLOON HAD BEEN INFLATED TO 12ATM. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE/DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT GRAPHIX (TM) WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MIAMI H74914914012 13969652

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention 1.5X15MM APEX BALLOON