BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERALD DIAGNOSTIC GUIDEWIRES

    MDR report key: 2941527 · Received February 4, 2013

    Report

    Report Number
    1016427-2013-00013
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K864058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE TUNISIAN MINISTRY OF HEALTH TESTING LABORATORY TESTED THE PRODUCTS-TWO (2 EACH) DGW.035 FC R1.5MM 180CM PTFE EMERALD DIAGNOSTIC GUIDEWIRES AFTER IMPORTATION CLEARANCE. IN THIS REPORT IT IS INDICATED THERE WAS A FILAMENT (A PIECE OF HAIR OR SIMILAR TISSUE) IN THE PACKAGING. THIS WAS CONCLUDED AS A NON CONFORMITY. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING AND NO BREAK IN THE STERILITY OF THE PACKAGING. THE PRODUCTS WERE NOT CLINICALLY USED AND WERE DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICES WERE NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL LIMITED AND WAS DETERMINED TO BE ACCEPTABLE. ALL EVIDENCE INDICATED THAT THE PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT. THE COMPLAINT COULD NOT BE CONFIRMED WITHOUT PHOTOS OR PRODUCT RETURN. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED OR CONTAMINATED PRODUCTS FROM LEAVING THE FACILITY, AND THE DEVICE HISTORY REVIEW CONFIRMED THAT THE PRODUCT MET SPECIFICATIONS. A REVIEW OF PAST 12 MONTHS OF COMPLAINT DATA REVEALED NO OTHER COMPLAINTS OF FOREIGN MATERIAL IN THE EMERALD DIAGNOSTIC GUIDEWIRE STERILE PACKAGE. SINCE THERE IS NO EVIDENCE TO SUGGEST THAT THE COMPLAINT WAS RELATED TO THE MANUFACTURING PROCESS, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS REPORT REPRESENTS TWO (2) PRODUCTS WITH THE SAME CATALOG NUMBER, SAME PRODUCT ISSUE, AND UNKNOWN LOT NUMBER. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE (B)(6) MINISTRY OF HEALTH TESTING LABORATORY TESTED THE PRODUCTS-TWO (2 EACH) DGW.035 FC R1.5MM 180CM PTFE DIAGNOSTIC GUIDEWIRES-AFTER IMPORTATION CLEARANCE. IN THIS REPORT IT IS INDICATED THERE WAS A FILAMENT (A PIECE OF HAIR OR SIMILAR TISSUE) IN THE PACKAGING. THIS WAS CONCLUDED AS NON CONFORMITY. TEST REPORTS ARE AVAILABLE FOR REVIEW. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCTS WERE NOT CLINICALLY USED AND WERE DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47160 EMERALD DIAGNOSTIC GUIDEWIRES ENDOVASCULAR WIRES & METALS (DQX) DQX CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1