BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRONTRUNNER XP CTO CATHETER SYSTEM

    MDR report key: 3103088 · Received May 9, 2013

    Report

    Report Number
    9616099-2013-00283
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 16, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K033535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN WAS SHAPING THE TIP OF THE FRONTRUNNER PRIOR TO USE AND THE JAWS ¿EXTRUDED AWAY FROM THE CATHETER BUT REMAINED ATTACHED.¿ THE DEVICE WAS NOT CLINICALLY USED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DIFFICULTY OPERATING (OPENING/CLOSING) THE DISTAL TIP (JAWS). THERE WAS NO DIFFICULTY MOVING THE HANDLE. SHAPING OF THE DISTAL TIP WAS ATTEMPTED WITH THE FINGERS. THE PROXIMAL PORT WAS FLUSHED PER THE IF. THE CATHETER WAS WIPED DOWN OR EMERGED IN HEPARINIZED SALINE PRIOR TO USE. THERE WAS NO BREAK IN DEVICE INTEGRITY OTHER THAN THE SEPARATION OF THE ACTUATING JAWS FROM THE CATHETER. ONE NON-STERILE CTO CATHETER FRONTRUNNER WAS RECEIVED COILED INSIDE A PLASTIC BAG. ONE BENT WAS OBSERVED APPROXIMATED AT 65.5 CM FROM STRAIN. BLUNT CAP WAS RECEIVED SEPARATED. NO OTHER ANOMALIES WERE OBSERVED IN THE CATHETER. THE FUNCTIONAL ANALYSIS WAS PERFORMED. NO ISSUES WERE NOTED WHEN THE ACTUATING JAWS WERE OPENED AND CLOSED. SEM ANALYSIS WAS PERFORMED TO IDENTIFY THE CAUSE OF BODY-DISTAL ASSEMBLY SEPARATION. THE BODY SEPARATION SURFACES PRESENTED EVIDENCE OF ELONGATION, WHICH IS A COMMON CHARACTERISTIC OF SAMPLES WHICH WERE PULLED/ STRETCHED UNTIL SEPARATION. THE DISTAL ASSEMBLY PRESENTS EVIDENCE OF BODY REMAINS ON ITS SEPARATION SURFACE, THIS CONDITION INDICATES THAT THE BODY WAS FUSED TO THE DISTAL ASSEMBLY AT A CERTAIN TIME. BASED ON THE AVAILABLE EVIDENCE IT IS VERY LIKELY THAT STRETCHING/ PULLING COULD HAVE BEEN RELATED TO THIS SEPARATION EVENT. NO OTHER ANOMALIES WERE FOUND. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT FAILURES FOUND ARE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR EVALUATION BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS SHAPING THE TIP OF THE FRONT RUNNER AND THE JAWS EXTRUDED AWAY FROM THE CATHETER. THEY DID NOT PUT THE FRONT RUNNER INTO THE PATIENT DUE TO THE SEPARATION. NO COMPLICATION OCCURRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202868 FRONTRUNNER XP CTO CATHETER SYSTEM CTO CATHETER SYSTEMS (DQY) DQY CORDIS DE MEXICO NA 15456174

    Patients

    Seq Age Sex Outcome Treatment
    1