BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACH1 GUIDE CATHETER

    MDR report key: 1080631 · Received July 22, 2008

    Report

    Report Number
    2134265-2008-02044
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    May 23, 2008
    Report Date
    July 16, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K010874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: PRODUCT ANALYSIS CONFIRMED SHAFT KINKED FOR THIS COMPLAINT. THE DEVICE WAS RETURNED IN 2 PIECES. THE RETURNED CATHETER EXHIBITED A KINK ON THE SHAFT LOCATED 1 CENTIMETER PROXIMALLY FROM WHERE THE END OF THE CATHETER WAS SPLIT INTO 2 PIECES. THE SECOND PIECE OF THE CATHETER WAS 3 CENTIMETERS IN LENGTH. THERE WAS NO INDICATION OF ELONGATION OF STRETCHING OF THE POLYMER OR BRAIDING MATERIAL. THE SEPARATION APPEARED TO BE COMPRESSED INDICATING IT WAS CUT. VISUAL AND MICROSCOPIC EXAMINATION OF THE MATERIAL SURROUNDING THE KINK DID NOT REVEAL ANY INHERENT DEFICIENCIES THAT WOULD HAVE CONTRIBUTED TO THE INCIDENT. IT WAS NOT POSSIBLE TO DETERMINE HOW OR WHEN THE KINK OCCURRED. A REVIEW OF THE MANUFACTURING RECORD FOR THIS PARTICULAR BATCH SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE EXACT CAUSE OF THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THIS EVENT IS REPORTABLE BASED ON THE PRODUCT ANALYSIS APPROVED ON 07/16/2008. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, THE GUIDE CATHETER KINKED. THE LESION BEING TREATED WAS LOCATED IN THE AVERAGE TORTUOUS PROXIMAL LEFT CIRCUMFLEX ARTERY,. THE 6FR MACH1 JL4 ST GUIDE CATHETER WAS INSERTED THROUGH RADIAL. "THE CATHETER WAS TORQUED FOR ENGAGING AND THE CATHETER UNDULY TURNED. THEREFORE, WHEN IT WAS GIVEN BACKSPIN, THE PHYSICIAN FELT THAT MOVEMENT OF THE GUIDE WIRE WAS BAD. THE PHYSICIAN CONFIRMED THAT THE TIP OF THE CATHETER WAS KINKED IN THE ARTERIA SUBCLAVIA." THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 6FR MACH1 JL4 ST GUIDE CATHETER. PATIENT STATUS IS REPORTED AS "GOOD". HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED THAT THERE WAS A SHAFT SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MACH1 GUIDE CATHETER DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC NA 0020050033

    Patients

    Seq Age Sex Outcome Treatment
    1