BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDE WIRES

    MDR report key: 1131444 · Received August 12, 2008

    Report

    Report Number
    2134265-2008-02296
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    July 12, 2008
    Report Date
    July 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    PMA / PMN Number
    K923480
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE GUIDE WIRE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PTCA/STENTING PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. THE PT PRESENTED WITH CHEST PAIN AND SHORTNESS OF BREATH. THE PT WAS TAKEN TO THE CARDIAC CATH LAB AND ANOTHER MFR'S STENT WAS PLACED IN THE 95% STENOSED OBTUSE MARGINAL VESSEL. A MAVERICK BALLOON CATHETER WAS USED TO POST DILATE THE STENT. WHILE ATTEMPTING TO REMOVE THE GUIDE WIRE AT THE END OF THE PROCEDURE, "THE DISTAL PART OF THE LOOP WAS PINNED AGAINST THE DISTAL END OF THE STENT AND WIRE BROKE". A 0.09 INCH SEGMENT OF THE GUIDE WIRE WAS LEFT IN THE PT. THE PT RETURNED 3 DAYS POST PROCEDURE, AND AN ATTEMPT WAS MADE TO RETRIEVE THE GUIDE WIRE FRAGMENT. THE PHYSICIAN WAS ABLE TO RETRIEVE THE "TERMINAL PORTION" OF THE GUIDE WIRE; HOWERVER, "RESIDUAL PORTIONS" OF THE GUIDE WIRE REMAINED IMBEDDED BEHIND THE STENT. THE PT WAS TRANSFERRED TO THE TELEMETRY UNIT FOR FURTHER OBSERVATION AND CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDE WIRES DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQX BOSTON SCIENTIFIC LUGE 300 J *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention 2.5X8 CYPHER STENT| 6 FR XP GUIDE CATHETER