BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATW MARKER GUIDEWIRE

    MDR report key: 3717888 · Received April 1, 2014

    Report

    Report Number
    1016427-2014-00037
    Event Type
    Injury
    Date Received
    April 1, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 12, 2014
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K994358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: A GC 7F 078 JR 4 VISTA BRITE TIP GUIDING CATHETER KINKED AND A J FLOPPY 300CM ATW GUIDEWIRE DISCONNECTED AT A HEAVY CALCIFIED LESION. THERE WAS NO PATIENT INJURY REPORTED. A NON-STERILE UNIT OF ATW MARKER GUIDE WIRE WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. A SECTION FROM DISTAL TIP END WAS OBSERVED SEPARATED FROM GUIDE WIRE, PROXIMATELY 26.5 CM; KINKS, BENTS, STRETCHED AND DETACHED COATING WAS OBSERVED IN THE SECTION SEPARATED. THE GUIDE WIRE BENT CONDITIONS WERE OBSERVED AT 20 CM AND 99.5 CM FROM DISTAL TIP SECTION. ONLY 4CM FROM DISTAL TIP SECTION WERE OBSERVED. THE GUIDE WIRE WAS INSPECTED UNDER VISION SYSTEM AND THE DAMAGES OBSERVED IN VISUAL ANALYSIS WERE CONFIRMED. DELIVERY WIRE WAS SENT TO SEM ANALYSIS IN ORDER TO DETERMINE THE CAUSE OF THE SEPARATION; RESULTS SHOWED THAT THE WIRE PRESENTED EVIDENCE OF REVERSE BENDING CONDITIONS, ELONGATIONS AND DUCTILE DIMPLES. REVERSE BENDING OR FATIGUE FAILURES COULD BE RELATED TO THESE SURFACE CHARACTERISTICS, THESE TYPES OF FAILURES OCCUR DUE TO A TENSILE OVERLOAD ALSO THESE TYPES OF FAILURES ARE CAUSED BY REPEATEDLY APPLIED LOAD. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10201012. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL LIMITED AND WAS DETERMINED TO BE ACCEPTABLE. THE REPORTED COMPLAINT ¿GUIDEWIRE/FRACTURED-SEPARATED/IN PATIENT¿ WAS CONFIRMED DUE TO THE CONDITION OF THE GUIDEWIRE UPON RECEIPT (A DISTAL TIP SECTION WAS RECEIVED FRACTURED). THE CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED VIA ANALYSIS. BASED ON THE INFORMATION AVAILABLE FOR REVIEW VESSEL CHARACTERISTICS (HEAVILY CALCIFIED LESION) AND PROCEDURAL FACTORS (AS EVIDENCED BY REVERSE BENDING CONDITIONS, ELONGATIONS AND DUCTILE DIMPLES FOUND IN ANALYSIS OF THE DEVICE) MAY HAVE CONTRIBUTED TO THE EVENT REPORTED. THE SEPARATED PORTION OF THE WIRE WAS ALSO NOTED TO HAVE SCRATCHES, STRETCHING, AND DETACHED COATING WHICH MAY INDICATE THAT FORCE WAS APPLIED TO THE DEVICE. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE REPORTED COMPLAINTS COULD NOT BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    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. THE GENDER OF THE PATIENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT A GC 7F 078 JR 4 VISTA BRITE TIP GUIDING CATHETER KINKED AND A J FLOPPY 300CM ATW GUIDEWIRE DISCONNECTED AT A HEAVY CALCIFIED LESION. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194033 ATW MARKER GUIDEWIRE CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA F1112046

    Patients

    Seq Age Sex Outcome Treatment
    1 VISTA BRITE TIP GUIDING CATHETER