BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUNWAY GUIDE CATHETER

    MDR report key: 1132760 · Received August 22, 2008

    Report

    Report Number
    2134265-2008-02419
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    PMA / PMN Number
    K033441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2008-02418. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE WITHDRAWAL RESISTANCE OCCURRED. THE 90% STENOSED, MILDLY CALCIFIED LESION WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY. THE PHYSICIAN CANULATED THE LESION WITH A RUNWAY GUIDE CATHETER AND A NON BSC GUIDE WIRE. THE LESION WAS PRE-DILATED USING A 2.0X9MM MAVERICK BALLOON. THE PHYSICIAN DEPLOYED A 3.0X16MM LIBERTE' MONORAIL CORONARY STENT AT 18ATM FOR 30 SECONDS IN THE LCX. THE STENT WAS FULLY DEPLOYED AND WELL APPOSED. HOWEVER, DURING WITHDRAWAL OF THE STENT DELIVERY SYSTEM, BALLOON WITHDRAWAL RESISTANCE WAS ENCOUNTERED. SUBSEQUENTLY, THE GUIDE CATHETER WAS SUCKED INTO THE VESSEL. MULTIPLE PICTURES WERE TAKEN AND NO DISSECTION WAS NOTED. THE WIRE AND GUIDE CATHETER WERE PULLED OUT. IT WAS NOTED THAT THE PHYSICIAN DID NOT FACE ANY TROUBLE INFLATING THE BALLOON ON THE STENT DELIVERY SYSTEM AND THE BALLOON WAS FULLY DEFLATED BEFORE ATTEMPTING TO PULL BACK. THERE WERE NO PATIENT COMPLICATIONS AND PATIENT STATUS AFTER PROCEDURE WAS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUNWAY GUIDE CATHETER DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 BMW UNIVERSAL 190CM-GUIDEWIRE