BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STABILIZER RADIOLUCENT

    MDR report key: 2804079 · Received October 25, 2012

    Report

    Report Number
    1016427-2012-00135
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    August 30, 2012
    Report Date
    August 30, 2012
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K873403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE NON STERILE GUIDE WIRE SGW STABILIZER .014 180CM J SOFT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE DISTAL TIP PRESENTED A KINK/BENT AT THE DISTAL END. THE COIL TIP PRESENTED AN UNRAVELED CONDITION AT DISTAL END. NO OTHER VISUAL DAMAGE WAS FOUND. THE DISTAL TIP AND COIL TIP WERE OBSERVED UNDER A MICROSCOPE AND THE DAMAGES WERE CONFIRMED. 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 INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE STATES THAT DURING THE PROCEDURE THE SGW STABLIZR .014 180CM J SOFT KINKED IN MIDDLE DURING FAILED ATTEMPTS TO CROSS THE TARGET LESION. . THE AGE AND GENDER OF THE PATIENT IS UNKNOWN. THE TARGET LESION IS UNKNOWN BUT LOCATED IN THE LEFT SYSTEM (LEFT SIDE CORONARY ARTERY). THE VESSEL WAS DESCRIBED AS CALCIFIED AND TORTUOUS. THE PRODUCT WAS PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. THE PHYSICIAN HAD DIFFICULTY ADVANCING THE STABLIZR GUIDEWIRE THROUGH THE VESSEL. WHEN HE REACHED THE TARGET LESION AND ATTEMPTED TO CROSS THE LESION, THE GUIDEWIRE KINKED. THEREFORE, THE WIRE WAS REMOVED AND ANOTHER GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. ONE NON-STERILE GUIDE WIRE SGW STABLIZR .014 180CM J SOFT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE DISTAL TIP PRESENTED A KINK/BENT AT THE DISTAL END. THE COIL TIP PRESENTED AN UNRAVELED CONDITION AT DISTAL END. NO OTHER VISUAL DAMAGE WAS FOUND. THE DISTAL TIP AND COIL TIP WERE OBSERVED UNDER A MICROSCOPE AND THE DAMAGES WERE CONFIRMED. (B)(4) DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10071384. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AND WAS DETERMINED TO BE ACCEPTABLE. THE REPORTED FAILURE BY THE COSTUMER AS 'GUIDEWIRE- KINKED/BENT' WAS CONFIRMED DUE TO PRODUCT RECEIVED CONDITIONS. THE CAUSE OF THIS REPORTED KINK AS WELL THE UNRAVELED CONDITION FOUND ON THE COIL TIP DURING ANALYSIS COULD NOT BE CONCLUSIVELY DETERMINED BUT IT DOES NOT APPEAR TO BE MANUFACTURING RELATED. THE FAILURE REPORTED BY THE CUSTOMER AS "GUIDEWIRE-FAILURE TO CROSS" COULD NOT BE EVALUATED; DUE TO THE NATURE OF THE COMPLAINT. 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). BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THERE ARE POSSIBLE VESSEL CHARACTERISTICS (CALCIFICATION AND TORTUOSITY) AND PROCEDURAL FACTORS (FAILED TO CROSS THE LESION) THAT MAY HAVE CONTRIBUTED TO THE KINK AND UNRAVELED CONDITION. 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

    THE ORIGINAL REPORT RECEIVED FROM THE AFFILIATE STATES THAT DURING THE PROCEDURE, THE SGW STABILIZER .014 180CM J SOFT KINKED IN MIDDLE. ANALYSIS REVEALED AN UNRAVELED CONDITION AT DISTAL END OF THE WIRE. THE AGE AND GENDER OF THE PATIENT IS UNKNOWN. THE TARGET LESION IS UNKNOWN BUT LOCATED IN THE LEFT SYSTEM (LEFT SIDE CORONARY ARTERY). THE VESSEL WAS DESCRIBED AS CALCIFIED AND TORTUOUS. THE PRODUCT WAS PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. THE PHYSICIAN HAD DIFFICULTY ADVANCING THE STABILIZER GUIDEWIRE THROUGH THE VESSEL. WHEN HE REACHED THE TARGET LESION AND ATTEMPTED TO CROSS THE LESION, THE GUIDEWIRE KINKED. THEREFORE, THE WIRE WAS REMOVED AND ANOTHER GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THERE WERE NO OTHER ANOMALIES NOTICED WHEN THE WIRE WAS INSPECTED AFTER REMOVAL. THE PRODUCT WAS RETURNED FOR EVALUATION AND ANALYSIS SHOWED THAT THE COIL TIP PRESENTED AN UNRAVELED CONDITION AT DISTAL END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STABILIZER RADIOLUCENT CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA 71111457

    Patients

    Seq Age Sex Outcome Treatment
    1