BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATW GUIDEWIRE

    MDR report key: 2963372 · Received February 15, 2013

    Report

    Report Number
    1016427-2013-00019
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K994358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER LAKE REGION REPORT (B)(4), LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10113002 (CORDIS LOT F0312129). THIS PACKAGING LOT CONTAINED (B)(4) UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL LIMITED ON APRIL 16, 2012. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL LIMITED AND WAS DETERMINED TO BE ACCEPTABLE. 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 BY AN AFFILIATE, AFTER OPENING THE PACKAGE, A SGW ATW .014 WAS FOUND UNRAVELED APPROXIMATELY 3CM FROM THE WIRE TIP. THE DEVICE WAS NOT CLINICALLY USED. THERE WAS NO DAMAGE TO THE SHIPPING BOX OR OUTER PRODUCT BOX. THE STERILE POUCH WAS NOT COMPROMISED. THE DEVICE HAD BEEN STORED IN THE LAB ACCORDING TO IFU. ONE NON-STERILE SGW ATW .014 STR FLOPPY 195CM WAS RECEIVED COILED INTO A PLASTIC BAG. THE DISTAL TIP PRESENTED AN UNRAVELED/STRETCHED CONDITION AT THE DISTAL END. THE COIL TIP WAS INSPECTED UNDER MICROSCOPE AND THE DAMAGE WAS CONFIRMED. THE DEVICE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL LIMITED AND WAS DETERMINED TO BE ACCEPTABLE. THE COMPLAINT REPORTED BY THE CUSTOMER AS 'DISTAL TIP - UNRAVELED/STRETCHED-PRIOR TO USE' WAS CONFIRMED DURING ANALYSIS; HOWEVER, THE CAUSE OF THE UNRAVELED/STRETCHED CONDITION COULD NOT BE CONCLUSIVELY DETERMINED. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD CONTRIBUTED TO THE EVENT AS REPORTED. 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 REPORTED BY AN AFFILIATE, AFTER OPENING THE PACKAGE, A SGW ATW .014 DEVICE WAS FOUND UNRAVELED APPROXIMATELY 3CM FROM THE WIRE TIP WAS FOUND UNRAVELED. THE DEVICE WAS NOT CLINICALLY USED. THERE WAS NO DAMAGE TO THE SHIPPING BOX. THERE WAS NO DAMAGE TO THE OUTER PRODUCT BOX. THE STERILE POUCH WAS NOT COMPROMISED. THE DEVICE HAD BEEN STORED IN THE LAB UNDER 30 DEGREES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68002 ATW GUIDEWIRE CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA F0312129

    Patients

    Seq Age Sex Outcome Treatment
    1