BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERALD DIAGNOSTIC GUIDEWIRES

    MDR report key: 2910950 · Received January 11, 2013

    Report

    Report Number
    1016427-2013-00005
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 21, 2012
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K864058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE DGW.035 FC STR SS 180CM PTFE WIRE CAME UNCOILED DURING USE. THE PRODUCT PACKAGING WAS OPENED IN STERILE FIELD. THERE WAS NO PATIENT INJURY REPORTED. MULTIPLE ATTEMPTS TO OBTAIN DETAILED PROCEDURAL INFORMATION WERE UNSUCCESSFUL. ONE NON-STERILE DGW.035 FC STR SS 180CM PTFE WAS RECEIVED COILED INTO A PLASTIC BAG. THE GUIDEWIRE PRESENTED NO VISUAL DAMAGED; THE DISTAL TIP PRESENTED AN UNRAVELED/STRETCHED CONDITION AT THE DISTAL END. THE DISTAL TIP WAS INSPECTED UNDER MICROSCOPE AND THE DAMAGE WAS CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THE COMPLAINT REPORTED BY THE CUSTOMER AS 'GUIDEWIRE - UNRAVELED/STRETCHED' WAS CONFIRMED DURING ANALYSIS. HOWEVER, THE UNRAVELED/STRETCHED CONDITION COULD NOT BE CONCLUSIVELY DETERMINED. IT IS POSSIBLE THAT PROCEDURAL/HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE EVENT REPORTED DURING PROCEDURE. THE FLEXIBLE, 'DELICATE' NATURE OF THE 'FLOPPY' TIP CONFIGURATION REQUIRES DUE CARE IN HANDLING AND USE, AS DIRECTED IN THE DEVICE INSTRUCTIONS FOR USE (IFU). THE DEVICE ANALYSIS DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD CONTRIBUTED TO THE EVENT AS REPORTED. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. NEITHER THE PRODUCT ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THE FAILURE COULD BE RELATED TO THE GUIDEWIRE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS RECEIVED, THE DGW.035 FC STR SS 180CM PTFE WIRE CAME UNCOILED DURING USE. THE PRODUCT PACKAGING WAS OPENED IN STERILE FIELD. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18814 EMERALD DIAGNOSTIC GUIDEWIRES ENDOVASCULAR WIRES & METALS (DQX) DQX CORDIS CORPORATION NA F0612148

    Patients

    Seq Age Sex Outcome Treatment
    1