BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUGE

    MDR report key: 1000128 · Received February 19, 2008

    Report

    Report Number
    2134265-2008-00453
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    PMA / PMN Number
    K923480
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT# 2134265-2008-00452. SAME CASE AS MFR REPORT# 2134265-2008-00455. SAME CASE AS MFR REPORT# 2134265-2008-00454. IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A GUIDE WIRE SEPARATION OCCURRED. THE LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PERCENT OF THE STENOSIS, DEGREE OF CALCIFICATION, AND VESSEL TORTUOUSITY ARE UNK. A 300CM LUGE GUIDE WIRE WAS ADVANCED TO THE LESION AND AN UNSPECIFIED 3.5MM X 12MM STENT WAS IMPLANTED IN THE LAD. A SECOND 300CM LUGE GUIDE WIRE WAS ADVANCED, HOWEVER, THE TWO GUIDE WIRES "COLLAPSED". THE PHYSICIAN ADVANCED A 3.5MM X 9MM MAVERICK BALLOON CATHETER ALONG ONE OF THE GUIDE WIRES AND A 2.5MM X 9MM MAVERICK BALLOON CATHETER ALONG THE OTHER GUIDE WIRE IN AN EFFORT TO RELEASE THE GUIDE WIRES BUT WAS UNSUCCESSFUL. TWO OTHER LUGE GUIDE WIRES WERE ADVANCED, HOWEVER, ALL 4 OF THE GUIDE WIRES BECAME ENTANGLED. UPON ATTEMPTING TO "YANK" THE GUIDE WIRES IN AN EFFORT TO RELEASE THEM, A PORTION OF ONE OF THE GUIDE WIRES "SHEARED OFF". THE PHYSICIAN ADVANCED ANOTHER MANUFACTURER'S SNARE DEVICE AND WAS ABLE TO SUCCESSFULLY RETRIEVE THE DETACHED PORTION OF THE GUIDE WIRE ALONG WITH THE 4 ENTANGLED GUIDE WIRES. THE PT'S STATUS IS REPORTED AS "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUGE DQX WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention 5FR PINNACLE SHEATH| 8FR JR 4.0 SH LAUNCHER| 2MM MICRO-SNARE KIT| 3.5MM X 9MM DRIVER OTW| 4MM MICRO-SNARE KIT| 6FR JL 4.0| 3.5MM X 12MM TAXUS STENT| 8FR FL 3.5 SH LAUNCHER| 8FR PINNACLE SHEATH| 6FR PINNACLE SHEATH| 4FR GOOSE NECK SNARE 5MM