BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDIS REFLEX STEERABLE GUIDEWIRE

    MDR report key: 5827026 · Received July 27, 2016

    Report

    Report Number
    1016427-2016-00019
    Event Type
    Malfunction
    Date Received
    July 27, 2016
    Date of Event
    June 27, 2016
    Report Date
    July 1, 2016
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K930091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS REPORTED, WHEN A SV WIRE (PGW .018 SV SHORT 300CM ST) WAS TAKEN OUT FROM ITS POUCH, THE DISTAL TIP WAS PEELED AND SEEMED LIKE THE CORE WIRE WAS COMING OUT. THERE WAS NO REPORTED PATIENT INJURY AS THE PRODUCT WAS NOT CLINICALLY USED. THE DEVICE WAS STORED PER INSTRUCTIONS FOR USE (IFU). IT IS UNKNOWN IF FORCE WAS USED WHEN REMOVING THE DEVICE FROM ITS PACKAGING. IT IS UNKNOWN IF HANDLING OF THE DEVICE COULD HAVE POTENTIALLY CONTRIBUTED TO THE REPORTED EVENT. PICTURES ARE NOT AVAILABLE FOR ANALYSIS. A NON-STERILE PGW .018 SV SHORT 300CM ST ENDOVASCULAR WIRE WAS RECEIVED FOR ANALYSIS COILED INSIDE A PLASTIC BAG. THE ORIGINAL PACKAGING WAS RETURNED FOR ANALYSIS. PER VISUAL ANALYSIS, THE WIRE WAS RECEIVED STRETCHED /UNRAVELED AT THE DISTAL TIP. NO OTHER ISSUES WERE FOUND. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE ABOVE MENTIONED LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE REPORTED EVENT BY THE CUSTOMER AS ¿DISTAL TIP-FRAYED/SPLIT/TORN-DURING PREP¿ AS WELL AS THE REPORTED EVENT BY THE CUSTOMER AS ¿EXPOSED BRAIDWIRE/COREWIRE (PERIPHERAL)-DURING PREP¿ WERE CONFIRMED DUE TO THE STRETCHED /UNRAVELED CONDITION OF UNIT AS RECEIVED. NONETHELESS, THE CAUSE OF THE STRETCHED/ UNRAVELED CONDITION COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS. ACCORDING TO THE PRODUCT INSTRUCTIONS FOR USE, USERS ARE WARNED THAT 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. NEITHER THE PRODUCT ANALYSIS NOR THE DEVICE HISTORY RECORD REVIEW SUGGESTS THAT UNRAVELED/STRETCHED CONDITION COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    WHEN A SV WIRE (PGW .018 SV SHORT 300CM ST) WAS TAKEN OUT FROM ITS POUCH, THE DISTAL TIP WAS PEELED AND SEEMED THAT THE CORE WAS COMING OUT. THERE WAS NO REPORTED PATIENT INJURY AS THE PRODUCT WAS NOT CLINICALLY USED. THE PRODUCT WAS NOT CLINICALLY USED AND IT WILL BE RETURNED FOR ANALYSIS. THE DEVICE WAS STORED PER IFU. IT IS UNKNOWN IF FORCE WAS USED WHEN REMOVING THE DEVICE FROM ITS PACKAGING. IT IS UNKNOWN IF HANDLING OF THE DEVICE COULD HAVE POTENTIALLY CONTRIBUTED TO THE REPORTED FAILURES. PICTURES ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477870 CORDIS REFLEX STEERABLE GUIDEWIRE ENDOVASCULAR WIRES & METALS (DQX) DQX CORDIS CORPORATION N/A 35227832

    Patients

    Seq Age Sex Outcome Treatment
    1