BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATW GUIDEWIRE (ALSO CALLED OSD)

    MDR report key: 1833504 · Received September 14, 2010

    Report

    Report Number
    1016427-2010-00104
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    December 31, 2009
    Report Date
    August 17, 2010
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K994358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT REPORT STATED THAT "DURING THE PROCEDURE, THE SGW ATW .014 STR FLOPPY 195 CM GUIDE GOT FRAYED LOOSING ROTATION AND ADVANCEMENT CAPABILITY." ATTEMPTS TO OBTAIN ADDITIONAL CLINICAL AND PROCEDURAL INFORMATION WERE UNSUCCESSFUL, AS "THE DOCTOR REFUSED TO GIVE THE INFORMATION TO J&J AGAIN." THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; IT WAS DISCARDED AT THE FACILITY. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL LIMITED AND WAS DETERMINED TO BE ACCEPTABLE. THE COMPLAINT COULD NOT BE CONFIRMED WITHOUT A PRODUCT RETURN. IN THE ABSENCE OF ANY CLINICAL OR PROCEDURAL DETAILS, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE SGW ATW 0.014 STR FLOPPY 195 CM GUIDE GOT FRAYED LOOSING ROTATION AND ADVANCEMENT CAPABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATW GUIDEWIRE (ALSO CALLED OSD) CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA F0109772

    Patients

    Seq Age Sex Outcome Treatment
    1