BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUNWAY GUIDE CATHETER

    MDR report key: 2861606 · Received December 7, 2012

    Report

    Report Number
    2134265-2012-07347
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K033441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: IT IS 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY TREATMENT PROCEDURE, GUIDE CATHETER SHAFT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A J WIRE WAS INSERTED AND A 6F RUNWAY GUIDE CATHETER WAS ADVANCED TOWARDS THE RCA. THE PHYSICIAN WAS TORQUING THE RUNWAY CATHETER IN AN ATTEMPT TO ENGAGE THE RCA WHEN THE CATHETER BEGAN TO TEAR/FRAY NEAR THE MID-SHAFT. THE CATHETER WAS HELD TOGETHER BY THE INTERNAL BRAIDING. THE CATHETER WAS WITHDRAWN INTO THE INTRODUCER SHEATH AND THEN A VASCULAR SURGEON CUT THE CATHETER AND WAS ABLE TO REMOVE THE CATHETER AND SHEATH TOGETHER. NOTHING DETACHED OR WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS ABORTED, AND IT WAS DECIDED TO TREAT THE PATIENT MEDICALLY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUNWAY GUIDE CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H749389695000

    Patients

    Seq Age Sex Outcome Treatment
    1 J WIRE