BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SGW STAB MARKER .014 180 J SS

    MDR report key: 8206438 · Received December 31, 2018

    Report

    Report Number
    1016427-2018-02372
    Event Type
    Malfunction
    Date Received
    December 31, 2018
    Date of Event
    December 3, 2018
    Report Date
    February 7, 2019
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K873403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER WAS CHANGED TO UNK AS THE LOT NUMBER PROVIDED IS NOT VALID. COMPLAINT CONCLUSION: AFTER OPENING THE INNER POUCH, IT WAS NOTED THAT THE PROXIMAL COIL OF THE SGW STABILIZER MARKER (.014 180 J SS) WIRE WAS EXPOSED. THERE WAS NO PATIENT INJURY. THE DEVICE WAS NOT CLINICALLY USED. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS STORED AS PER LABELING AND WAS OPENED IN A STERILE FIELD. THERE WERE NO OTHER ANOMALIES NOTED ON THE DEVICE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY REVIEW COULD NOT BE PERFORMED SINCE THE COMPLAINT LOT IS UNKNOWN. THE REPORTED ¿GUIDEWIRE EXPOSED BRAIDWIRE/COREWIRE - DURING PREP¿ COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND DEVICE IMAGES WERE NOT RECEIVED. THE EXACT CAUSE COULD NOT BE DETERMINED. STORAGE AND HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE EVENT, AS STATED IN THE INSTRUCTIONS FOR USE, WHICH IS NOT INTENDED AS A MITIGATION, ¿STORE IN A COOL, DARK, DRY PLACE. DO NOT USE OPEN OR DAMAGED PACKAGES. USE PRIOR TO THE ¿USE BY¿ DATE. EXPOSURE TO TEMPERATURES ABOVE 54C (130F) MAY DAMAGE THE GUIDEWIRE. OPEN THE STERILE PACKAGE SLOWLY. TO PREVENT DAMAGE TO THE DISTAL TIP OF THE GUIDEWIRE AND TO PREVENT THE GUIDEWIRE FROM SPRINGING ONTO A NON-STERILE FIELD, CAREFULLY REMOVE THE GUIDEWIRE FROM THE DISPENSING TUBE. USE THE DISPENSER WINDOW TO ADVANCE THE GUIDEWIRE DISTAL TIP, SUCH THAT THE GUIDEWIRE CAN BE REMOVED BY GRASPING THE COATED SHAFT. NOTE: DO NOT PULL THE DISTAL TIP TO REMOVE GUIDEWIRE FROM DISPENSER AS IT MAY DAMAGE THE TIP. GUIDEWIRES ARE DELICATE INSTRUMENTS AND SHOULD BE HANDLED CAREFULLY. PRIOR TO USE AND WHEN POSSIBLE DURING THE PROCEDURE, INSPECT THE GUIDEWIRE CAREFULLY FOR COIL SEPARATION, BENDS, OR KINKS. DO NOT USE A GUIDEWIRE THAT SHOWS SIGNS OF DAMAGE. DAMAGE WILL PREVENT THE GUIDEWIRE FROM PERFORMING WITH ACCURATE TORQUE RESPONSE AND CONTROL.¿ WITHOUT A LOT NUMBER TO CONDUCT A PRODUCT HISTORY RECORD REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED EVENT COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED, IT WAS NOTED AFTER OPENING THE INNER POUCH THAT THE PROXIMAL COIL OF SGW STABILIZER MARKER (.014 180 J SS) WIRE WAS EXPOSED. THERE WAS NO PATIENT INJURY. THE DEVICE WAS STORED AS PER LABELING AND WAS OPENED IN A STERILE FIELD. THE PRODUCT WAS NOT CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS. THERE WERE NO OTHER ANOMALIES NOTED ON THE DEVICE. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED, IT WAS NOTED AFTER OPENING THE INNER POUCH THAT THE PROXIMAL COIL OF SGW STABILIZER MARKER (.014 180 J SS) WIRE WAS EXPOSED. THERE WAS NO PATIENT INJURY. THE DEVICE WAS STORED AS PER LABELING AND WAS OPENED IN A STERILE FIELD. THE PRODUCT WAS NOT CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045879 SGW STAB MARKER .014 180 J SS WIRE, GUIDE, CATHETER DQX CORDIS CORPORATION 518224J UNK

    Patients

    Seq Age Sex Outcome Treatment
    1