BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUNWAY GUIDE CATHETER

    MDR report key: 2091844 · Received May 17, 2011

    Report

    Report Number
    2134265-2011-01790
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K033441
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURE, A VESSEL DISSECTION OCCURRED. THE 95% STENOSED LESION BEING TREATED WAS LOCATED IN THE MODERATELY TO SEVERELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED WITH A 12X2.0MM APEX BALLOON CATHETER. THE PHYSICIAN ADVANCED A 12X3.0MM PROMUS STENT DELIVERY SYSTEM (SDS) TO THE LESION VIA THE 6F RUNWAY GUIDE CATHETER. THE SDS WOULD NOT CROSS THE LESION. THE RUNWAY GUIDE CATHETER WAS DEEP SEATED IN THE RIGHT CORONARY ARTERY CAUSING A VESSEL DISSECTION WHICH THEN "PROPAGATED INTO THE ASCENDING AORTA AND THEREFORE, PATIENT HAD TO BE SENT TO EMERGENCY SURGERY." FOLLOWING THE DISSECTION THERE WAS A DECREASE IN THE PATIENT'S HEART RATE AND BLOOD PRESSURE. THE SURGERY SUCCESSFULLY REPAIRED THE AORTA AND BYPASS OF THE RCA WAS PERFORMED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    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 72 YR Required Intervention 3.0X12MM PROMUS STENT| 2.0X12MM APEX BALLOON CATHETER