BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE FLOPPY EXTRA SUPPORT GUIDE WIRE

    MDR report key: 140370 · Received December 19, 1997

    Report

    Report Number
    2024168-1997-00287
    Event Type
    Malfunction
    Date Received
    December 19, 1997
    Date of Event
    October 24, 1997
    Report Date
    December 1, 1997
    Manufacturer
    GUIDANT ACS/DVI
    Product Code
    DQX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QA ASSURANCE ANALYSIS CONFIRMED THAT THE COILS WERE PUSHED FROM THE CENTER SOLDER. THE TIP WAS CANDY CANE SHAPED. THE RIBBON AND CORE WERE INTACT. QUALITY ENGINEERING CONCLUDED THAT THE CONDITION OF THE COILS APPEARS TO HAVE BEEN FROM IMPROPER REMOVAL FROM THE DISPENSER. IF THE COILS ARE GRASPED DURING REMOVAL FROM THE DISPENSER, THE COILS MAY BE PUSHED DISTAL CAUSING THE TIP TO BECOME WAVY/KINKED. THE INITIAL MDR WAS FILED DUE TO THE REPORT BEING THAT THE TIP HAS SEPARATED. SUBSEQUENTLY, THE DEVICE WAS RETURNED AND ANALYSIS REVEALED IT WAS NOT SEPARATED, BUT STRETCHED. THIS NO LONGER MEETS MDR FILING CRITERIA. AS PART OF CO'S QUALITY PROCESS. 100% OF ALL GUIDE WIRES ARE INSPECTED DURING THE PACKAGING PHASE OF MFG MICROSCOPICALLY FOR DAMAGE, BENDS, KINKS TO ENSURE PROPER DEVICE STRUCTURE AND INTEGRITY. NO CORRECTIVE ACTION WILL BE IMPLEMENTED. THIS MDR IS CONSIDERED CLOSED BY THE QA DEPT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE GUIDE WIRE WAS OPENED FOR USE, THE TIP SEPARATED. THE PRODUCT WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE FLOPPY EXTRA SUPPORT GUIDE WIRE GUIDE WIRE DQX GUIDANT ACS/DVI NA 7080451

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other