BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUNWAY GUIDE CATHETER

    MDR report key: 901089 · Received October 20, 2006

    Report

    Report Number
    6000093-2006-02144
    Event Type
    Malfunction
    Date Received
    October 20, 2006
    Date of Event
    August 16, 2006
    Report Date
    August 16, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED PRODUCT ANALYSIS VERIFIED THE DIFFICULTY STATED IN THE COMPLAINT. THE CATHETER WAS RECEIVED WITH THE HUB DETACHED AND THE SHAFT IN 2 PIECES. THE PROXIMAL PORTION OF THE SHAFT EXHIBITED 3 SHAFT KINKS LOCATED 2.5, 14.0 AND 41.3 CENTIMETERS DISTALLY FROM THE EDGE OF THE STRAIN RELIEF, ONE OF WHICH EXHIBITED UNBROKEN EXPOSED BRAID. THE DISTAL PORTION OF THE SHAFT EXHIBITED NUMEROUS KINKS. THE LOCATION OF THE SHAFT SEPARATION IS APPROXIMATELY 45 CENTIMETERS FROM THE STRAIN RELIEF. DESTRUCTIVE ANALYSIS REVEALED OUTER SHAFT IMPRESSIONS INSIDE THE HUB, INDICATING THE CATHETER WAS ASSEMBLED PROPERLY. VISUAL AND MICROSCOPIC EXAMINATION OF THE MATERIAL SURROUNDING THE KINKS DID NOT REVEAL ANY INHERENT DEFICIENCIES THAT WOULD HAVE CONTRIBUTED TO THE INCIDENT. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 7892050 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE OF THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DETERMINED TO BE REPORTABLE BASED ON ANALYSIS COMPLETED ON 09/20/2006. IT WAS REPORTED THAT DURING A PTCA TREATMENT PROCEDURE, A HUB BREAK OCCURRED. THE LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN WAS TORQUING THE GUIDE CATHETER AND THE HUB DISCONNECTED FROM THE SHAFT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT COMPLICATIONS OR INJURIES WERE NOTED. PATIENT STATUS IS REPORTED AS "OKAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUNWAY GUIDE CATHETER GUIDE CATHETER DQO BOSTON SCIENTIFIC 6F RUNWAY JL6 7892050

    Patients

    Seq Age Sex Outcome Treatment
    1 YR